Device 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
Z-0349-2023
Product summary
- Event
- Event 91054
- Status
- Terminated
- Classification
- Class III
- Quantity
- 340 kits
- Official record key
device-enforcement:Z-0349-2023
Official wording
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 information: Lot 12161
Distribution pattern: Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Derived failure modes
-
Unknown
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.