Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC)

Hazard

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

Details from the source

Reason for recall: Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Distribution: 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 Quantity: 23751 Lot/code info: 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

UPC codes

10758750030729

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.