FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
- Recall number
- Z-1112-2025
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
- Status
- Open, Classified
- Initiated
- 2025-01-02
- Posted
- 2025-02-05
- Terminated
- not on file
- Reason
- Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall letter was sent during the week of December 30, 2024, to the affected customers via first class mail and email. If a passing calibration curve can be generated using the Access PCT reagent lots listed above, no action is needed. If repeated calibration failures with a failure code of Max Iterate are obtained using the Access PCT reagent lots listed above, discontinue using the affected reagent lot number.
- Quantity
- 6,994 US; 10,067 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.
- Lot, serial or model codes
- UDI-DI 15099590736002 Lots 339062, 439811
- 510(k) numbers
- ["K192271"]
- PMA numbers
- not on file
- Product code
- PTF
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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