VITROS XT Chemistry Products TBIL-ALKP Slides — Class II medical device recall Z-2623-2023
Ongoing recall by Ortho-Clinical Diagnostics, INc., reported 2023-09-27, distributed nationwide. Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in
| Recall number | Z-2623-2023 |
|---|---|
| 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 | 2023-08-05 |
| Classified | 2023-09-21 |
| Reported by FDA | 2023-09-27 |
| 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, PT, RU, SE, SG |
| Quantity | 52,456 units |
| UPC / GTIN / UDI-DI | 10758750031801 |
Product
VITROS XT Chemistry Products TBIL-ALKP Slides
Reason for recall
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
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-2623-2023. 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.