The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or mo

FDA device recall Z-1698-2011 · posted 2011-03-17 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

The use of the device assemblies has been extended to a 6 month useful life.

Action taken

The firm, Abbott Laboratories, sent a "Product Correction" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or email QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S. please contact your local hematology customer support representative.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

874

Distribution

Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and coun

Date initiated

2009-11-30

Date posted

2011-03-17

Date terminated

2011-03-18

Location

Santa Clara, CA

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