Recalls / —
—#200526
Product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
- FDA product code
- OYA — P2psa
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P090026
- Affected 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.
Why it was recalled
Reagent lot numbers include an insufficient concentration of blocking reagent.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
The recalling firm issued letters to U.S. consignees dated 5/15/2023 via first class mail and email on 5/17/2023. The letter described the issue, impact, and the action to be taken. The consignee was instructed to discontinue using the reagent lots that were listed and discard all remaining reagent packs from the lots. The letter was to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The Beckman Coulter representative was to be contacted for replacement product requests. If the product was forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee is requested to respond within 10 days of receipt of the letter either electronically or manually by completing the enclosed Response Form. The letter for the OUS consignees was dated 5/16/2023 and was similar to the letter for the U.S. consignees.
Recalling firm
- Firm
- Beckman Coulter, Inc.
- Address
- 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037
Distribution
- 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.
Timeline
- Recall initiated
- 2023-05-17
- Posted by FDA
- 2023-06-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #200526. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.