ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML — Class II medical device recall Z-1836-2025
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2025-06-04, distributed nationwide. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be
| Recall number | Z-1836-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2025-04-24 |
| Classified | 2025-05-27 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10758750007448 |
| Model numbers | 6901935 |
Product
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Reason for recall
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
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-1836-2025. 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.