Agency classClass IIOur severity:High FDA (Devices)·Z-2187-2018·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Roche Diabetes Care, Inc. is recalling 295,248 units of Accu-Chek Inform II Test Strips, Catalog no. 05942861001. The recall involves Lot 476340, which was distributed nationwide in the United States and to numerous foreign countries.

The recalling firm identified that the affected test strips are out of specification. These strips have an increased potential for errors before a blood sample is applied, failure to be detected by the meter once inserted, or the production of biased results that may not be detectable. If a biased result occurs, users might take incorrect actions based on the displayed blood glucose value rather than the actual value.

Consumers should stop using the affected test strips and contact Roche Diabetes Care for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA.

The recalled product

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…
Manufacturer: Roche Diabetes Care, Inc.
Category: Medical Device — Blood Glucose Monitoring
Hazard: mis-labeling
incorrect-result
Affected units: 295,248

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 (1)

Lot 476340

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Roche Diabetes Care, Inc.

See all →

High
Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units
FDA (Devices) · 2024-07-03
High
Diabetes Management Software May Display Wrong Patient Data
FDA (Devices) · 2022-05-04
High
Accu-Chek Inform II glucose test strips may open during shipment
FDA (Devices) · 2021-09-01
High
Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
FDA (Devices) · 2021-09-01
High
Accu-Chek Performa Test Strips Recalled Due to Defective Packaging
FDA (Devices) · 2021-09-01

Same hazard · mis labeling