FDA Device recall Z-1004-2015
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integ…
- FDA Device
- Class III
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class III recall of VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integ… by Ortho Clinical Diagnostics, citing calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1004-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | CO, MI, NC, NJ, NY, PA, WV |
Product
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Reason
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Identifiers
| code_info | System Product Code: 1) 6802445, 2) 6802413 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2015%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.