# FDA recall Z-1799-2020

> **Beckman Coulter Inc.** · Class II · device recall initiated 2019-06-12.

## Product

SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.

## Reason for recall

The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.

## Distribution

Worldwide distribution - US Nationwide distribution and to multiple countries.

## Key facts

- **Recall number:** Z-1799-2020
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-12
- **Report date:** 2020-05-06
- **Termination date:** 2020-12-11

- **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-1799-2020

## Citation

> AI Analytics. FDA recall Z-1799-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1799-2020. Source: US FDA. Licensed CC0.

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