CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
- Company
- Abbott Laboratories
- Recall Initiated
- January 15, 2008
- Posted
- April 24, 2008
- Terminated
- December 23, 2010
- Recall Number
- Z-1165-2008
- Quantity
- 2,746 syringes were distributed.
- Firm Location
- Santa Clara, CA
Reason for Recall
Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.
Distribution
Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
Lot / Code Info
All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".
Root Cause
Process control
Action Taken
On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.