FDA Enforcement
Class III
Terminated
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
Recall: Z-0349-2023
·
Reported December 7, 2022
Enforcement
- Recall Number
- Z-0349-2023
- Event ID
- 91054
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Primus Corporation dba Trinity Biotech
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 7, 2022
- Initiation Date
- October 5, 2021
- Classification Date
- December 1, 2022
- Termination Date
- August 9, 2023
- Address
- 4231 E 75th Ter, Kansas City, MO, 64132-2059, United States
Description
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
Reason
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.
Code Info
Lot 12161
Distribution
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Quantity
340 kits