Terminated

Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

FDA Recall Z-0175-2015 · Posted 2014-11-06

Recalling FirmBeckman Coulter Inc.

Recall StatusTerminated

Product CodeJJE

Date Initiated2014-10-06

Date Terminated2015-06-29

Product Quantity1,519 units total (403 units total)

Reason for Recall

Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.

Firm Action

An Urgent Medical Device Recall Letter dated 10/6/14 was sent to all customers who purchased the Small Form Factor Console PC for use with the Access 2 Immunoassay Systems Family. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers are instructed to contact their local Beckman Coulter representative.

Root Cause

Vendor change control

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121214ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEMBeckman Coulter, Inc. · 2013-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.