FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1267-2018
- Recalling firm
- Medica Corporation
- 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.
- Status
- Terminated
- Initiated
- 2017-04-11
- Posted
- not on file
- Terminated
- 2019-08-20
- 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.
- Quantity
- not on file
- Distribution
- USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
- Lot, serial or model codes
- Medica s Lot # 16292
- 510(k) numbers
- ["K120497"]
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 1220972
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28