VITROS Chemistry Products PHYT Slides — Class II medical device recall Z-2344-2018
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-07-11, distributed nationwide. There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coat
| Recall number | Z-2344-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-05-09 |
| Classified | 2018-07-03 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Quantity | 5,712 |
| Lot numbers | 2616-0165-4866, 2616-0165-4869, 2616-0165-4870, 2616-0165-4904, 2616-0165-5232, 2616-0165-5233, 2616-0165-5266, 2616-0165-5307, 2616-0165-5610, 2616-0165-5611, 2616-0165-5648, 2616-0165-5649, 2616-0165-6218, 2616-0165-6219, 2616-0165-6220, 2616-0165-6221, 2616-0165-6275, 2616-0165-6276, 2616-0165-6787, 2616-0165-6791, 2616-0165-6792, 2616-0165-6832, 2616-0165-7214, 2616-0165-7222, 2616-0165-7223, 2616-0165-7225, 2616-0165-7226 |
| Model numbers | 8298671 |
Product
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Reason for recall
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
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-2344-2018. 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.