VITROS Software Version 3 — Class III medical device recall Z-1004-2015
Terminated recall by Ortho-Clinical Diagnostics, reported 2015-01-28, distributed in CO, MI, NC, NJ, NY, PA, WV. Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrat
| Recall number | Z-1004-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2014-09-29 |
| Classified | 2015-01-20 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2017-04-03 |
| Distributed | CO, MI, NC, NJ, NY, PA, WV |
| Countries outside the US | CA, ES, JP |
| Quantity | 12 units |
| Reason classes | labeling |
Product
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Reason for recall
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
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-1004-2015. 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.