VITROS Chemistry Products FS Diluent Pack 3 — Class II medical device recall Z-2266-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-07-10, distributed nationwide. VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used t
| Recall number | Z-2266-2024 |
|---|---|
| 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 | 2024-05-21 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 1,000 |
| UPC / GTIN / UDI-DI | 10758750007004 |
| Lot numbers | 01-1645 |
| Model numbers | 6801754 |
| Expiration dates | 2024-07-05 |
Product
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Reason for recall
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
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-2266-2024. 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.