Z-2043-2023 Class II Ongoing
FDA device recall Z-2043-2023 was initiated by Beckman Coulter, Inc. on May 17, 2023 and is designated Class II. Reason for recall: Reagent lot numbers include an insufficient concentration of blocking reagent. The recall status is ongoing. Affected quantity: 987 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 987 kits
Product Description
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Reason for Recall
Reagent lot numbers include an insufficient concentration of blocking reagent.
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.
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.