# FDA recall Z-1628-2023

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2023-04-17.

## 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 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

## Key facts

- **Recall number:** Z-1628-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-17
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1628-2023

## Citation

> AI Analytics. FDA recall Z-1628-2023. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1628-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*