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.
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling the Synchron Systems Opiate 2000 ng Reagent (catalog number 475006) used with UniCel DxC 600/800 Systems for drug of abuse testing. The reagent may not perform cross-reactivity testing as described in its instructions for use, which could cause certain compounds in urine samples to produce false positive or false negative results for opiate detection. The recall affects 1,610 units distributed throughout the United States and Puerto Rico, including multiple states from California to Hawaii, with specific lot numbers M904147, M810039, M901087, M805122, and older lots.
The affected reagent lots were distributed across numerous healthcare facilities and testing laboratories in the recalled states. The source document does not specify a remedy or recommended action for consumers or affected facilities.
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 2000 ng (OP2) 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 2000 ng (OP2) 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: 1610 units Lot/code info: Catalog Number 475006 ; UDI: 15099590222031; Lot Numbers: M904147 and older including M810039, M901087 and M904147) and 4 lots OP2 (M805122, M810039, and M901087. .
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.