# FDA recall Z-0269-2020

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-09-10.

## Product

VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.

## Reason for recall

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

## Distribution

Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

## Key facts

- **Recall number:** Z-0269-2020
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2019-11-13
- **Termination date:** 2020-11-13

- **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-0269-2020

## Citation

> AI Analytics. FDA recall Z-0269-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0269-2020. Source: US FDA. Licensed CC0.

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