medical Class II Updated 2023-07-05

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

Recalled Product

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.


Hazard / Issue

Reagent lot numbers include an insufficient concentration of blocking reagent.

Issued by

FDA

Affected States: CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, WA
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.
View official government recall

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