White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued May 14, 2008).
- Company
- Abbott Laboratories
- Recall Initiated
- December 19, 2007
- Posted
- May 14, 2008
- Terminated
- July 2, 2008
- Recall Number
- Z-1103-2008
- Quantity
- Product was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Distribution
Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and WV, and countries of: Argentina, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Singapore, South Korea and Venezuela.
Lot / Code Info
Lot Numbers: 51749i2, 51754i2 and 56675i2.
Root Cause
Material/Component Contamination
Action Taken
Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.