The Recall Desk

Manufacturer

Roche Diabetes Care, Inc.

29 recalls in our database name Roche Diabetes Care, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
29
Critical
0
Severe
4
Most recent
2024-07-03

Of the 29 recalls from Roche Diabetes Care, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 29

  • HighFDA (Devices)·Z-2174-2024·2024-07-03

    Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units

    Roche is recalling Accu-Chek Guide (SC) blood glucose meters that may display readings in mmol/L instead of mg/dL, appearing approximately 18 times lower than actual. This could lead to incorrect treatment decisions and long-term diabetes complications.

    Product
    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2022·2022-05-04

    Diabetes Management Software May Display Wrong Patient Data

    Roche Diabetes Care Platform Software version 2.5.2 may display incorrect patient data when users navigate between patient records using the browser back button. No illnesses have been reported.

    Product
    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2021·2021-09-01

    Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.

    Product
    Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2021·2021-09-01

    Accu-Chek Inform II glucose test strips may open during shipment

    Roche Diabetes Care is recalling Accu-Chek Inform II glucose test strips because vials may open during shipment, exposing strips to humidity and potentially causing inaccurate test results.

    Product
    Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2021·2021-09-01

    Accu-Chek Performa Test Strips Recalled Due to Defective Packaging

    Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes treatment decisions.

    Product
    Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2021·2021-09-01

    Accu-Chek SmartView Test Strips May Open During Shipment

    Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.

    Product
    Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2020·2020-02-12

    Roche Accu-Chek Aviva Test Strips Recalled for Dosing Issues

    Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.

    Product
    ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2020·2020-02-12

    Roche Recalls Accu-Chek Aviva Plus Blood Glucose Test Strips

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.

    Product
    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2020·2020-02-12

    Roche Recalls Accu-Chek Aviva Plus Blood Glucose Test Strips

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.

    Product
    Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.

    Product
    Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues

    Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems

    Roche Diabetes Care is recalling specific Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues.

    Product
    Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.

    Product
    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0751-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling 355,400 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 33 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2019·2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2766-2019·2019-10-09

    Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor

    Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2019·2019-10-02

    Accu-Chek Connect App Recall for Android Data Transfer Failure

    Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2018·2018-06-20

    Roche Recalls Accu-Chek Aviva Plus Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.

    Product
    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2018·2018-06-20

    Roche Recalls Accu-Chek Performa Test Strips Due to Potential Measurement Errors

    Roche Diabetes Care is recalling Accu-Chek Performa test strips because they may produce biased results or fail to detect blood samples, potentially leading to incorrect user actions.

    Product
    Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2018·2018-06-20

    Roche Recalls Accu-Chek Inform II Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling Accu-Chek Inform II test strips because they may produce errors or biased results, potentially leading to incorrect user actions.

    Product
    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2018·2018-02-21

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Software Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a software bug may cause incorrect unit changes, risking inaccurate blood glucose data or carbohydrate input.

    Product
    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2018·2017-12-13

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a bug in the Bolus Advisor feature may prevent correction bolus advice from being available for recent glucose readings.

    Product
    Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2017·2017-05-10

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Error

    Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.

    Product
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1099-2017·2017-02-01

    Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors

    Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Roche Diabetes Care GmbH (Germany)

company in Mannheim, Germany

Country
Germany

Official website

Source: Wikidata (Q140046216), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.