VITROS chemistry Products K+ Slides — Class II medical device recall Z-0269-2020
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-11-13, distributed nationwide. Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen fai
| Recall number | Z-0269-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-09-10 |
| Classified | 2019-11-01 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-11-13 |
| 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, PL, PT, RU, SE, SG |
| Quantity | 1,365,545 total |
| UPC / GTIN / UDI-DI | 00410209950196, 00410209960591, 00410209991939, 00410210003645, 00410210003669, 00410210003775, 00410210013798, 00410210013996, 00410210014061, 00410210066947, 00410210066992, 00410210085986, 00410210086198, 00410210096494, 00410210137302, 00410210169822, 00410210179951, 00410210200457 |
| Model numbers | 8157596 |
Product
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Reason for recall
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
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-0269-2020. 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.