# FDA recall Z-0770-2021

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2020-12-11.

## Product

VITROS Chemistry Products CKMB Slides:    (1)VITROS CKMB Slides (60 Slide cartridge)  Product Code:8058232     (2)VITROS CKMB Slides (18 Slide cartridge)  Product Code: 8001133    Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

## Reason for recall

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia,	India, Japan, Mexico, Singapore 609917, United Kingdom, 	France, Germany, Italy, Spain, Portugal, Poland, Russia, 	Denmark, Norway, Sweden, Belgium, The Netherlands.

## Key facts

- **Recall number:** Z-0770-2021
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-11
- **Report date:** 2021-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0770-2021

## Citation

> AI Analytics. FDA recall Z-0770-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0770-2021. Source: US FDA. Licensed CC0.

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