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Terminated

Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.

FDA Recall Z-0046-2013 · Posted 2012-10-10

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeCGN
Date Initiated2012-07-24
Date Terminated2013-10-17
Product Quantity4,635 units total (3,214 units in US)

Reason for Recall

Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

Firm Action

Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated July 24, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to complete and return the enclosed Response Forms within 10 days. Customers with questions were instructed to call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060774FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208Beckman Coulter, Inc. · 2006-04-21

Official Source

View FDA Recall →

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

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