Recall Z-1267-2018 ยท JIT Calibrator, Secondary
Medica Corporation
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.
| Date | Apr 11, 2017 |
| Status | Terminated |
| Reason | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL Medica Corp., May 14, 2012 |