Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Acce
FDA device recall Z-0175-2015 · posted 2014-11-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1,519 units total (403 units total)
- Distribution
- Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colomb
- Date initiated
- 2014-10-06
- Date posted
- 2014-11-06
- Date terminated
- 2015-06-29
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM (K121214) | Beckman Coulter, Inc. | 2013-06-14 |