FDA Device recall Z-1222-2019
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended f…
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended f… by Ortho Clinical Diagnostics, citing 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 report….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1222-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-11 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | Systems Running Software Version 3.4 & 3.4.1 |
|---|
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-1222-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.