medical Class II Updated 2020-04-29

Beckman Coulter Inc. recalls Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction wi

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. .
View official government recall

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