Home / Recalls / Beckman Coulter Inc. / Z-2074-2017

Z-2074-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
April 13, 2017
Termination Date
June 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,278 units total (2,419 units in US)

Product Description

Access BR Monitor, Part No. 387620

Reason for Recall

Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).

Distribution Pattern

Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe

Code Information

623913, 625701, 628771, 630349, 633070 and All Future Lots

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  • Z-0541-2026 Class II — DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The (September 22, 2025)
  • Z-0216-2026 Class II — DxI 9000 Access Immunoassay Analyzer, Part Number C11137 (September 19, 2025)