FDA Medical Device Recalls (openFDA)
Primus Corporation dba Trinity Biotech: A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
- Recall number
- Z-0349-2023
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Product
- A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
- Status
- Terminated
- Initiated
- 2021-10-05
- Posted
- 2022-12-01
- Terminated
- 2023-08-09
- Reason
- The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices.
- Quantity
- 340 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Lot, serial or model codes
- Lot 12161
- 510(k) numbers
- ["K952720"]
- PMA numbers
- not on file
- Product code
- JPK
- Firm FEI
- 1931251
- Firm city
- Kansas City
- Firm state
- MO
- 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