The Recall Desk

Manufacturer

Roche Diagnostics Corporation

39 recalls in our database name Roche Diagnostics Corporation as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
2
Most recent
2019-07-24

Of the 39 recalls from Roche Diagnostics Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (5%) 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.

26–39 of 39

  • ModerateFDA (Devices)·Z-1270-2018·2018-04-04

    Roche cobas e 411 Analyzer Recall for Questionable Results

    Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.

    Product
    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2018·2018-04-04

    Roche Modular E 170 Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.

    Product
    Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2018·2018-03-14

    Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury

    Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent operator injury during maintenance.

    Product
    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0910-2018·2018-03-14

    Roche cobas 8000 Modular Analyzer Recall for Operator Injury Prevention

    Roche Diagnostics is recalling 245 cobas 8000 c 502 modules to add a warning to the manual, preventing operator injury during maintenance.

    Product
    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0498-2018·2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2018·2018-02-07

    Roche Elecsys 2010 Analyzer Software Malfunction Recall

    Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.

    Product
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2018·2018-01-24

    Roche Recalls Automated Analyzers Due to Possible Sample Mismatch

    Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.

    Product
    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2017·2017-06-14

    Roche Cobas Connection Module Recalled for Vibration and Contamination Risk

    Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.

    Product
    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2173-2017·2017-06-07

    Roche Recalls PreciControl Varia 3 Due to Typographical Error

    Roche Diagnostics is recalling 1,603 units of Elecsys PreciControl Varia 3 because the e-barcode and value sheet contain a typographical error for PTH target values.

    Product
    Elecsys PreciControl Varia 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2017·2017-05-17

    Roche Diagnostics Recalls Sample Probes for Corrosion-Related Liquid Level Detection Issues

    Roche Diagnostics is recalling 3,946 sample probes for cobas analyzers because corrosion on electrical contacts can disrupt liquid level detection, potentially causing sample carryover.

    Product
    Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2017·2017-04-19

    Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1763-2017·2017-04-19

    Roche Recalls Cobas 8100 Modules Due to Potential Sample Spillage

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a software issue can cause rack crashes and sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states

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 Diagnostics

Swiss diagnostic company

Founded
1896
Parent company
Hoffmann-La Roche

Official website

Source: Wikidata (Q1592110), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.