VITROS XT 7600 Integrated System — Class II medical device recall Z-1222-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-05-01, distributed nationwide. One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of th
| Recall number | Z-1222-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-03-11 |
| Classified | 2019-04-25 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, ES, FR, GB, IN, IT, JP, PT, SG |
| Quantity | 80 |
| Reason classes | software |
Product
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Reason for recall
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
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-1222-2019. 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.