# FDA recall Z-1930-2020

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2020-04-01.

## Product

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.

## Reason for recall

The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1930-2020
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-01
- **Report date:** 2020-05-20
- **Termination date:** 2021-01-19

- **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-1930-2020

## Citation

> AI Analytics. FDA recall Z-1930-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1930-2020. Source: US FDA. Licensed CC0.

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