EasyCAL HbA1c Calibrator — Class II medical device recall Z-1267-2018
Terminated recall by Medica Corporation, reported 2018-04-04, distributed in CA, FL, MI, PR, TX. Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate fals
| Recall number | Z-1267-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medica Corporation, Bedford, MA, United States |
| Recall initiated | 2017-04-11 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-08-20 |
| Distributed | CA, FL, MI, PR, TX |
| Countries outside the US | IN, RU |
| Lot numbers | 16292 |
| Model numbers | 10658 |
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.
Reason for recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1267-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.