Recall Z-1799-2020— Beckman Coulter Inc.

Name: FDA recall Z-1799-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-12

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-06-12, terminated 2020-12-11. It names one FDA 510(k) clearance: K944075. 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: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Terminated: 2020-12-11
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K944075 — CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYSTBeckman Instruments, Inc.·cleared 1994-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.