VITROS Chemistry Products CRP Slides- In vitro diagnostic… — Class II medical device recall Z-0535-2025
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-12-04, distributed nationwide. May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than
| Recall number | Z-0535-2025 |
|---|---|
| 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 | 2024-10-11 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 7,717 units |
| UPC / GTIN / UDI-DI | 10758750000296 |
| Model numbers | 1926740 |
| Expiration dates | 2024-10-01, 2025-01-01 |
Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Reason for recall
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
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-0535-2025. 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.