Beckman Coulter, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2043-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Product Classification:

Class II

Date Initiated: May 17, 2023

Date Posted: July 5, 2023

Recall Number: Z-2043-2023

Event ID: 92369

Reason for Recall:

Reagent lot numbers include an insufficient concentration of blocking reagent.

Status: Ongoing

Product Quantity: 987 kits

Code Information:

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.

Distribution Pattern:

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, Switzerland, Taiwan, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated