Trinity Biotech HbA1c recall
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Why was Trinity Biotech HbA1c recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 0539151674808, Lot 12161
- Product
- Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Quantity
- 182 kits
- Distribution
- Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- Recall date
- December 7, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)