Beckman Coulter Inc. recalls SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction…

Recall date

June 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1799-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and to multiple countries.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.