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Beckman Coulter Inc. recalls Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300
Recalled April 29, 2020 · FDA recall Z-1752-2020 · Beckman Coulter
Hazard
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. · FDA Class II
Units
7,951 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →