EasyCAL HbA1c Calibrator recall
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.
Why was EasyCAL HbA1c Calibrator recalled?
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Medica s Lot # 16292
- 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.
- Recalling firm
- Medica Corporation
- Distribution
- USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)