VITROS Chemistry Products CHE Slides — Class II medical device recall Z-2123-2025
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2025-07-23, distributed nationwide. Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of chol
| Recall number | Z-2123-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2025-06-10 |
| Classified | 2025-07-17 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 414,000 |
| Reason classes | labeling, specification failure |
| UPC / GTIN / UDI-DI | 10758750030293, 10758750030309 |
| Model numbers | 10758750030293, 10758750030309, 4074, 4138, 684 |
Product
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Reason for recall
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2123-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.