Class II — Medica Corporation
| Recalling firm | MEDICA CORP. |
|---|---|
| Registered facility | MEDICA CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. |
| 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. |
| Distribution | USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau. |
| Initiated | 2017-04-11 |
| Classified | 2018-03-28 |
| Terminated | 2019-08-20 |
| Recall number | Z-1267-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medica Corporation (Z-1267-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77160/
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