FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
- Recall number
- Z-2043-2023
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
- Status
- Open, Classified
- Initiated
- 2023-05-17
- Posted
- 2023-06-30
- Terminated
- not on file
- Reason
- Reagent lot numbers include an insufficient concentration of blocking reagent.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 987 kits
- Distribution
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P090026"]
- Product code
- OYA
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28