Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
FDA Recall Z-1112-2025 · Posted 2025-02-05
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Recalling FirmBeckman Coulter Inc.
Recall StatusOpen, Classified
Product CodePTF
Date Initiated2025-01-02
Product Quantity6,994 US; 10,067 OUS
Reason for Recall
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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