Recall Z-0046-2013 ยท CGN Acid, Folic, Radioimmunoassay
Beckman Coulter Inc.
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 defic
| Date | Oct 10, 2012 (initiated Jul 24, 2012) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 4,635 units total (3,214 units in US) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 Beckman Coulter, Inc., Apr 21, 2006 |