# FDA recall Z-0165-2018

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2017-09-29.

## Product

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77  Clinical Chemistry systems.

## Reason for recall

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000  has the possibility to leak due to a manufacturing issue associated with the tubing connector.

## Distribution

Worldwide distribution to US, Canada, France, and Germany.

## Key facts

- **Recall number:** Z-0165-2018
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-09-29
- **Report date:** 2017-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2018

## Citation

> AI Analytics. FDA recall Z-0165-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0165-2018. Source: US FDA. Licensed CC0.

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