Recall Z-1751-2020— Beckman Coulter Inc.

Name: FDA recall Z-1751-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-04

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-09-04, terminated 2021-04-28. It names one FDA 510(k) clearance: K984152. Product: Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.. Reason: Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-04
Terminated: 2021-04-28
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K984152 — SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENTBeckman Coulter, Inc.·cleared 1999-01-29

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 Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.

Reason for recall

Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

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