—#67154

Product

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

FDA product code: GGK — Products, Red-Cell Lysing Products
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K051215, K961439
Affected lot / code info: Lot Numbers: 51749i2, 51754i2 and 56675i2.

Why it was recalled

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-12-19
Posted by FDA: 2008-05-14
Terminated: 2008-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.