VITROS Chemistry Products CRBM Slides — Class II medical device recall Z-1470-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-04-23, distributed in IN, MD, TN. The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM
| Recall number | Z-1470-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2014-03-05 |
| Classified | 2014-04-17 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2017-02-28 |
| Distributed | IN, MD, TN |
| Quantity | 20 units |
| Lot numbers | 3920-0080-8403 |
| Model numbers | 2382, 889 |
| Expiration dates | 2014-06-15 |
Product
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for recall
The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
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-1470-2014. 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.