# FDA recall Z-1927-2019

> **Roche Diagnostics Corporation** · Class III · device recall initiated 2019-04-04.

## Product

cobas p 501 post-analytical units, Part Number 05158494001.  For diagnostic sample storage and retrieval.

## Reason for recall

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

## Distribution

US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

## Key facts

- **Recall number:** Z-1927-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-04
- **Report date:** 2019-07-10
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2019

## Citation

> AI Analytics. FDA recall Z-1927-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1927-2019. Source: US FDA. Licensed CC0.

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