Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
A. MENARINI diagnostics Hb 9210 PREMIER Recalled by Primus Corporation dba Trinity Biotech Due to The Control Level I material value was showing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Primus Corporation dba Trinity Biotech directly.
Affected Products
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
Quantity: 340 kits
Why Was This Recalled?
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.
Where Was This Sold?
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
About Primus Corporation dba Trinity Biotech
Primus Corporation dba Trinity Biotech has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report