VITROS 5 — Class II medical device recall Z-0643-2016
Terminated recall by Ortho-Clinical Diagnostics, reported 2016-01-20, distributed nationwide. Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatur
| Recall number | Z-0643-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2016-01-13 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2018-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IL, IN, IT, JP, KE, MX, PA, PH, PL, RO, RU, SG, TR, TW, VE |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10758750001132, 10758750001644 |
| Serial numbers | 34000123, 34000133, 34000143, 34000191, 34000193, 34000197, 34000212, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000285, 34000316, 34000318, 34000319, 34000331, 34000337, 34000360, 34000380, 34000382, 34000406, 34000408 and 200 more |
| Model numbers | 6801375, 6801890 |
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).
Reason for recall
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
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-0643-2016. 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.