FDA Device recall Z-1933-2019
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine,…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine,… by Ortho Clinical Diagnostics, citing potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1933-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-08 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Reason
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Identifiers
| code_info | All lots |
|---|
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-1933-2019%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.