VITROS Chemistry Products Li — Class II medical device recall Z-1471-2017
Terminated recall by Ortho-Clinical Diagnostics, reported 2017-03-22, distributed in PR. Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
| Recall number | Z-1471-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2017-02-01 |
| Classified | 2017-03-15 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-06-29 |
| Distributed | PR |
| Countries outside the US | BR, CA, CL, CN, DO |
| UPC / GTIN / UDI-DI | 10758750004720, 10758750009466 |
| Lot numbers | 04-01, 05-01, 2018, 3124-0108-6568, 3124-0108-6569 |
Product
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.
Reason for recall
Intermittent imprecision in results generated using two specific lots of VITROS Li 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-1471-2017. 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.