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.
FDA Recall Z-1267-2018 · Posted None
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Recalling FirmMedica Corporation
Recall StatusTerminated
Product CodeJIT
Date Initiated2017-04-11
Date Terminated2019-08-20
Reason for Recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Firm 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.
Root Cause
Process design
Distribution Pattern
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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