FDA Device recall Z-2185-2019
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer by Ortho Clinical Diagnostics, citing potential Unsuccessful Calibration Due to Software Anomaly in VITROS System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2185-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-08 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Reason
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Identifiers
| code_info | product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above |
|---|
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-2185-2019%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.