Reported Apr 4, 2018 · Terminated
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for…
Medica Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medica Corporation · 5 Oak Park Dr · Bedford, MA · 01730-1430
Is this the product you have?
- 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.
- Lot codes and dates
- Medica s Lot # 16292
Where it was sold
Why it was recalled
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
This product could cause temporary or reversible health problems — stop using it.
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