Beckman Coulter Inc.: Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Hazard

Lipemic interference failed to meet the performance specification listed within the IFU.

Details from the source

Reason for recall: Lipemic interference failed to meet the performance specification listed within the IFU. Distribution: US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cura¿ao, Cyprus, Czechia, Denmark, Ecuador, Egypt, France, Germany, Gibraltar, Greece, Hong Kong, Hungar Quantity: 12,850 units Lot/code info: All Lots/UDI-(01)15099590011574

UPC codes

15099590011574

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.