Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassa
FDA device recall Z-0050-2012 · posted 2011-10-17 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.
- Action taken
- The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs. Customers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification. Finally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 14,764
- Distribution
- Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finla
- Date initiated
- 2009-03-05
- Date posted
- 2011-10-17
- Date terminated
- 2012-04-27
- 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 TOTAL BHCG (K023480) | Beckman Coulter, Inc. | 2002-12-20 |