Z-1267-2018 Class II Terminated
FDA device recall Z-1267-2018 was initiated by Medica Corporation on April 11, 2017 and is designated Class II. Reason for recall: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. The recall status is terminated (terminated August 20, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- April 11, 2017
- Termination Date
- August 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Reason for Recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Distribution Pattern
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Code Information
Medica s Lot # 16292