VITROS Chemistry Products CRP Slides — Class III medical device recall Z-1615-2013
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-07-03, distributed nationwide. While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfact
| Recall number | Z-1615-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-05-09 |
| Classified | 2013-06-27 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2015-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Model numbers | 192, 6740, 7990, 809 |
| Expiration dates | 2013-10-01, 2013-11-01 |
Product
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) 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
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
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-1615-2013. 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.