Trinity Biotech Hb 9210 Premier Hemoglobin A1c Controls Recall: Unreliable Results After 3
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61715-trinity-biotech-hb-9210-premier-hemoglobin-a1c-controls-recall-unreliable.
Source Summary by GovInfoNow · govinfonow.com/recall/61715-trinity-biotech-hb-9210-premier-hemoglobin-a1c-controls-recall-unreliable · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0349-2023
Cite this page
“Trinity Biotech Hb 9210 Premier Hemoglobin A1c Controls Recall: Unreliable Results After 3.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61715-trinity-biotech-hb-9210-premier-hemoglobin-a1c-controls-recall-unreliable. Based on FDA recall #Z-0349-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0349-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Trinity Biotech- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0349-2023 | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis; Lot 12161 | 340 kits |
| Z-0350-2023 | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis; UDI/DI 0539151674808, Lot 12161 | 182 kits |
What to do — step by step
Check Control Results
If your device shows an error code after three months, stop using the control kit immediately.
How this recall unfolded
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0349-2023 (October 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0349-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.