# FDA recall Z-1934-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-04-08.

## Product

VITROS 250AT Chemistry System, Product Code 1758143,  (UDI # 10758750000036)    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 for recall

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1934-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-08
- **Report date:** 2019-07-10
- **Termination date:** 2020-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2019

## Citation

> AI Analytics. FDA recall Z-1934-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1934-2019. Source: US FDA. Licensed CC0.

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