Z-0350-2023 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 5, 2021
- Termination Date
- August 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182 kits
Product Description
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
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.
Distribution Pattern
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Code Information
UDI/DI 0539151674808, Lot 12161