Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent imm
FDA device recall Z-0046-2013 · posted 2012-10-10 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
- Action taken
- 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
- Status
- Terminated
- Product code
- CGN
- Quantity affected
- 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,
- Date initiated
- 2012-07-24
- Date posted
- 2012-10-10
- Date terminated
- 2013-10-17
- Location
- Brea, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774) | Beckman Coulter, Inc. | 2006-04-21 |