# FDA recall Z-0308-2018

> **Beckman Coulter Inc.** · Class III · device recall initiated 2017-11-06.

## Product

Access 2 Immunoassay System, Catalog Number 81600N.    In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

## Reason for recall

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

## Distribution

Worldwide Distribution -- US,  Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-0308-2018
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-06
- **Report date:** 2018-01-10
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0308-2018

## Citation

> AI Analytics. FDA recall Z-0308-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0308-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*