Trinity Biotech recalls Hb 9210 Premier hemoglobin A1c controls that show unreliable results after 3 months, causing test delays and potential treatment delays. Affected units include specific lot numbers and model types.
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. 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 hemoglobin A1c control kits that may give inaccurate results after three months of use. This can cause delays in patient testing and treatment adjustments, which is serious for people managing diabetes.
The control kits may show results outside the acceptable range after three months. This causes the testing device to stop working and invalidate patient samples, leading to delayed treatment decisions for diabetes management.
People using these hemoglobin A1c control kits for diabetes testing are affected. Those with diabetes who rely on frequent lab tests are at higher risk of delayed treatment.
Check for the model name 'Hb 9210 PREMIER', level 'LEVEL1' or 'LEVEL II', and lot number 12161. The product was sold with reference number 45052 and part number 05-01-0926.
If your device shows an error code after three months, stop using the control kit immediately.
The control kits may show results exceeding the acceptable range after three months, causing the device to stop testing and delay patient results.
You should check if your device shows an error code after three months. If so, stop using the control kit immediately.
Look for the model name 'Hb 9210 PREMIER', level 'LEVEL1' or 'LEVEL II', and lot number 12161. The product was sold with reference number 45052 and part number 05-01-0926.
We’ve drafted a message you can send Trinity Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0349-2023 — Trinity Biotech Trinity Biotech Hello, I own a Trinity Biotech that is covered by recall Z-0349-2023 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.
