Z-1267-2018Class II
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant...
Medica Corp. / initiated 2017-04-11 / Terminated / root cause: manufacturing process
Medica Corporation began a recall of 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... on . FDA classified it as Class II and gives the reason as "Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1267-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medica Corp.
- 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.
- Product code
- JIT Calibrator, Secondary
- Reason for recall
- Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- 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.
- Distribution
- USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
- Product codes and lots
- Medica s Lot # 16292
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1267-2018 | Class II | Terminated | Voluntary: Firm initiated |
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