Device product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Z-2043-2023
Product summary
- 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
Reagent lot numbers include an insufficient concentration of blocking reagent.