VITROS CHEMISTRY PRODUCTS TRIG Slides — Class II medical device recall Z-0848-2015
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-12-31, distributed nationwide. Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
| Recall number | Z-0848-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2014-11-06 |
| Classified | 2014-12-22 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Lot numbers | 0704-3318-4774 |
| Model numbers | 133, 6544 |
| Expiration dates | 2015-12-01 |
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) 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
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
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-0848-2015. 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.