Device product
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Z-1267-2018
Product summary
- Event
- Event 77160
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1267-2018
Official wording
Reason: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Code information: Medica s Lot # 16292
Distribution pattern: USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Derived failure modes
-
Unknown
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.