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.
This recall has been terminated (originally issued April 11, 2017).
- Company
- Medica Corporation
- Recall Initiated
- April 11, 2017
- Terminated
- August 20, 2019
- Recall Number
- Z-1267-2018
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Distribution
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Lot / Code Info
Medica s Lot # 16292
Root Cause
Process design
Action Taken
Consignees were notified of the recall via email bulletin dated 4/11/17. The bulletin informs customers of the issues and explains the actions to be taken.
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