VITROS XT 7600 Integrated System — Class II medical device recall Z-1364-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-05-29, distributed nationwide. Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to
| Recall number | Z-1364-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-03-20 |
| Classified | 2019-05-20 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CL, ES, IN, IT, JP, KR |
| Reason classes | potency |
| Serial numbers | 76000108 |
Product
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Reason for recall
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
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-1364-2019. 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.