Recall Z-2014-2011
Abbott Laboratories · initiated March 15, 2011
Product
CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
Codes / lots: List Number 02H30-01; lot number 20071AN; Refurbished list number: 02H030-03; lot numbers 20478AN96, 20390AN96, and 20421AN96.
Reason for recall
The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
FDA-determined cause: Pending
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.
Details
- Recall number
- Z-2014-2011
- Initiated
- March 15, 2011
- Posted by FDA
- April 29, 2011
- Terminated
- November 22, 2011
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 174 total instruments, 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, and Chile.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2015-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2016-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2017-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2018-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2019-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2020-2011 | CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |