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Recall Observatory FDA recall evidence

Device 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.

Z-1267-2018

April 11, 2017

Class II

Product summary

Firm
Medica Corporation
Event
Event 77160
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1267-2018

Official wording

Reason: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

Code information: Medica s Lot # 16292

Distribution pattern: USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.