FDA Device recall Z-1267-2018
EasyCAL HbA1c Calibrator
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of EasyCAL HbA1c Calibrator by Medica, citing patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1267-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-11 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medica |
| Distribution | CA, FL, MI, PR, TX |
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
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Identifiers
| code_info | Medica s Lot # 16292 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.