Beckman Coulter Inc.: Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Hazard

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.

Details from the source

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. 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, T Quantity: 6,994 US; 10,067 OUS Lot/code info: UDI-DI 15099590736002 Lots 339062, 439811

UPC codes

15099590736002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.