Trinity Biotech recalls HbA1c controls kits that may show results beyond acceptable limits after 3 months, causing test errors and delayed patient results.
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Trinity Biotech is recalling HbA1c control kits that may show results outside the acceptable range after three months. This causes the blood test analyzer to stop testing and delay patient results, potentially affecting diabetes treatment timing.
The control kit's results may exceed the acceptable range after three months. This causes the blood analyzer to generate an error code, stopping further testing and nullifying patient samples. As a result, diabetes test results are delayed, which could affect timely treatment adjustments.
People using the Trinity Biotech HbA1c control kits for diabetes testing are affected. Those who have the specific kit model with the part number 05-01-0040B are most at risk.
Check for the part number 05-01-0040B on the kit. The kit was sold with the reference number 01-04-0020 and lot number 12161.
Look for the part number 05-01-0040B on the kit label to confirm if it is recalled.
The control kit may show results exceeding the acceptable range after three months, causing the analyzer to stop testing and delay patient results.
Delayed test results could affect timely treatment adjustments for diabetes management.
Check for the part number 05-01-0040B on the kit label. The kit was sold with reference number 01-04-0020 and lot number 12161.
We’ve drafted a message you can send Trinity Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0350-2023 — Trinity Biotech Trinity Biotech Hello, I own a Trinity Biotech that is covered by recall Z-0350-2023 from Trinity Biotech. 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.
