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.
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling Opiate 300 ng reagent kits used with UniCel DxC 600/800 and SYNCHRON systems for drug testing. The reagent may not perform cross-reactivity testing as claimed in its instructions, which could cause certain compounds in urine samples to produce incorrect test results—either falsely indicating the presence of opiates when none are present or failing to detect opiates that are actually present.
The affected reagent kits were distributed throughout the United States and Puerto Rico. A total of 7,951 units are involved, identified by catalog number 475024 and specific lot numbers ranging from M802097 through M904130. The recall record does not specify a remedy or instructions for what affected consumers should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY. Quantity: 7,951 units 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. .
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.