VITROS¿ Black Reference Slides CATALOG #: J02316 — Class II medical device recall Z-1489-2021
Terminated recall by Ortho-Clinical Diagnostics, INc., reported 2021-05-05, distributed nationwide. Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as Wh
| Recall number | Z-1489-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, INc., Rochester, NY, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Lot numbers | 9252-0058-3361, 9252-0058-3362 |
| Model numbers | J02316 |
Product
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Reason for recall
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
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-1489-2021. 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.