The Recall Desk
HighFDA (Devices)·Z-2354-2021·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device where the hazard (inaccurate glucose readings) could result in inappropriate medical treatment. No illnesses or injuries have been reported. The harm is conditional and potential rather than confirmed, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diabetes Care, Inc. is recalling Accu-Chek Inform II Test Strips (Model number 05942891001). Test strip vials may open while sealed in cartons during shipment. When vials open, the test strips inside can be exposed to humidity, which may damage the strips and result in inaccurate glucose readings.

Inaccurate test results could lead to inappropriate therapy decisions and adverse health consequences for patients who rely on accurate glucose readings to manage diabetes.

The recall affects Accu-Chek Inform II test strips distributed nationwide in the United States and worldwide. This recall applies to all non-expired lots of the product.

The recalled product

Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Glucose Test Strip
Hazard
  • vial-opening
  • humidity-damage
  • inaccurate-readings

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Since this is a labeling correction
  • this recall is not lot specific and is applicable to all non-expired lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category