The Recall Desk

FDA (Devices) recall action 88362

Roche Diabetes Care, Inc. recalled 4 products on 2021-09-01

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-09-01
Critical
0
Units
1,150,755

Why these products were recalled

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states