CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
- Company
- Abbott Laboratories
- Recall Initiated
- March 15, 2011
- Posted
- April 29, 2011
- Terminated
- November 22, 2011
- Recall Number
- Z-2016-2011
- Quantity
- 174 instruments total, all varieties
- Firm Location
- Santa Clara, CA
Reason for Recall
The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
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.
Lot / Code Info
List Number 91350-01; lot numbers: 31222P, 32091P Refurbished list number: 91350-03; lot number: 32159P96
Root 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.