A. MENARINI diagnostics Hb 9210 PREMIER recall
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c…
Why was A. MENARINI diagnostics Hb 9210 PREMIER 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 12161
- Product
- A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c…
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Quantity
- 340 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Recall date
- December 7, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)