FDA recall Z-1799-2020

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1799-2020