Beckman Coulter, Inc.: Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Hazard

Reagent lot numbers include an insufficient concentration of blocking reagent.

Details from the source

Reason for recall: Reagent lot numbers include an insufficient concentration of blocking reagent. Distribution: Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Sw Quantity: 987 kits Lot/code info: Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134; and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133.

UPC codes

15099590211325, 15099590204112

Source

Official record: FDA (Device enforcement) ↗

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