Recall Z-0349-2023
Primus Corporation dba Trinity Biotech · initiated October 5, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: Lot 12161
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0349-2023
- Initiated
- October 5, 2021
- Posted by FDA
- December 1, 2022
- Terminated
- August 9, 2023
- Product code
- JPK – Mixture, Hematology Quality Control
- Quantity
- 340 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Recalling firm
- Primus Corporation dba Trinity Biotech, Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0350-2023 Class III | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part…The Control Level I material value was showing results exceeding the upper limit of the acceptable range… | 10/05/2021Terminated |