CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, Santa Clara, CA 05054
FDA device recall Z-2019-2011 · posted 2011-04-29 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Action taken
- Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
- Root cause
- Pending
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 174 total units, all varieties
- Distribution
- Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, an
- Date initiated
- 2011-03-15
- Date posted
- 2011-04-29
- Date terminated
- 2011-11-22
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |