A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052,
FDA device recall Z-0349-2023 · posted 2022-12-01 · Terminated
Recall details
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Reason for recall
- 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.
- Action taken
- The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 340 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Date initiated
- 2021-10-05
- Date posted
- 2022-12-01
- Date terminated
- 2023-08-09
- Location
- Kansas City, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II (K952720) | Aalto Scientific, Ltd. | 1995-09-20 |