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Recall Observatory FDA recall evidence

Device product

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Z-2043-2023

May 17, 2023

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 92369
Status
Ongoing
Classification
Class II
Quantity
987 kits
Official record key
device-enforcement:Z-2043-2023

Official wording

Reason: Reagent lot numbers include an insufficient concentration of blocking reagent.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reagent lot numbers include an insufficient concentration of blocking reagent.