Recall Z-1752-2020— Beckman Coulter Inc.

Name: FDA recall Z-1752-2020
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: K031002. Product: Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.. Reason: Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)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

K031002 — SYNCHRON SYSTEMS OPIATE REAGENTBeckman Coulter, Inc.·cleared 2003-04-29

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

Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

Reason for recall

Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)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.