Roche recalls specific Accu-Chek Inform II test strips that may cause inaccurate glucose readings, leading to incorrect diabetes management decisions. Affected lots show potential for strip errors or undetected strips.
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.
Roche is recalling certain Accu-Chek Inform II test strips that could give inaccurate blood glucose readings. This might lead to incorrect diabetes treatment decisions if users rely on the results.
The recalled test strips may not function correctly, causing errors in glucose measurement. This could lead to incorrect actions by users based on the displayed results, potentially affecting diabetes management.
People using the Accu-Chek Inform II test strips for home blood glucose monitoring. Those with diabetes who rely on these strips for daily glucose checks are most at risk.
Check the lot number on the test strip packaging. The affected lots include 476340. The product is sold under the Accu-Chek Inform II system.
Look for the lot number on the test strip packaging. The affected lot is 476340.
The recalling firm identified two lots of test strips that are out of specification, which may cause errors in glucose measurement.
Check the lot number on the test strip packaging. If it is 476340, contact Roche for guidance.
The recall does not require immediate stop use, but users should check the lot number and contact Roche if they have the affected lot.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2187-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-2187-2018 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
