Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
FDA device recall Z-0350-2023 · posted 2022-12-01 · Terminated
Recall details
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Reason for recall
- The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 182 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Date initiated
- 2021-10-05
- Date posted
- 2022-12-01
- Date terminated
- 2023-08-09
- Location
- Kansas City, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II (K952720) | Aalto Scientific, Ltd. | 1995-09-20 |