Recall Z-1112-2025
Beckman Coulter Inc. · initiated January 2, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Codes / lots: UDI-DI 15099590736002 Lots 339062, 439811
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1112-2025
- Initiated
- January 2, 2025
- Posted by FDA
- February 5, 2025
- Product code
- PTF – Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA