--- title: "VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... — FDA record Z-1628-2023 | Is It on Recall" description: "Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis" url: https://isitonrecall.com/recall/fda-device-z-1628-2023-vitros-chemistry-products-hba1c-reagent-kit-ivd-for-the-quantitative-determination-of-percent-glycat/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1... — FDA record Z-1628-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Apr 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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**: Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis - **Classification**: Class II - **Recalling firm**: Ortho-Clinical Diagnostics, Inc. - **Quantity**: 23751 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1628-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1628-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1628-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ortho-Clinical Diagnostics, Inc. records](https://isitonrecall.com/brand/ortho-clinical-diagnostics-inc/)