FDA Device recall Z-1364-2019
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
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of 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 by Ortho Clinical Diagnostics, citing potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1364-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-20 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Identifiers
| code_info | Serial Number 76000108 thru current. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2019%22
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