Z-1628-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- April 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23751
Product Description
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Reason for Recall
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Distribution Pattern
US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom
Code Information
UDI-DI: 10758750030729 Lot Number/Expiry: 29-9396 2023-SEP-02; 29-9466 2023-SEP-02; 30-9647 2023-NOV-25; 30-9803 2023-NOV-25; 31-9648 2024-JAN-24; 32-9925 2024-APR-14; 33-1097 2024-JUL-18; 33-1105 2024-JUL-18; 33-1228 2024-JUL-18; 34-1345* 2024-OCT-17. All lots within expiry (listed above) as well as future lots until your laboratory receives an additional notification from Ortho