[Recalled] 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 — The Control Level I material value was showing results exceeding the u
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 analysis |
|---|---|
| Brand / manufacturer | Primus Corporation dba Trinity Biotech |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0349-2023 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 05 October 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.