VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 — Class II medical device recall Z-2580-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-08-21, distributed nationwide. It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of f
| Recall number | Z-2580-2024 |
|---|---|
| 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 | 2024-07-03 |
| Classified | 2024-08-12 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, DE, DK, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 18,467 units |
| Model numbers | 1513266 |
Product
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Reason for recall
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
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-2580-2024. 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.