CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

Accu-Chek Inform II Test Strip, Whole blood glucose test system recalled

Roche Diabetes Care is recalling Accu-Chek Inform II Test Strip, Whole blood glucose test system, distributed nationwide in the US. The recall was initiated on 7 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 476340

Quantity recalled295,248

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2187-2018
FDA event ID: 80018
Recalling firm: Roche Diabetes Care, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2018
FDA classified: 14 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Insulin Pumps & Glucose Monitors

Timeline

7 May 2018	Recall initiated by company
14 Jun 2018	Classified by FDA	+38 days
20 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

Where it was distributed

Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 476340

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 80018

This product is part of a recall event; the main page for the event is Accu-Chek Performa Test Strip, Blood glucose monitoring system recalled.

Reported	Class	Recall	Company	Reason	Where
20 Jun 2018	CLASS II	Accu-Chek Performa Test Strip, Blood glucose monitoring system recalled	Roche Diabetes Care	Potency & Assay	Nationwide
20 Jun 2018	CLASS II	Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system recalled	Roche Diabetes Care	Potency & Assay	Nationwide

More recalls from Roche Diabetes Care

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1 Sep 2021Device	CLASS II	Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System recalled	Roche Diabetes Care	Labeling Errors	Nationwide
1 Sep 2021Device	CLASS II	Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System recalled	Roche Diabetes Care	Labeling Errors	Nationwide
1 Sep 2021Device	CLASS II	Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System recalled	Roche Diabetes Care	Labeling Errors	Nationwide

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