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Terminated

The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories to human waste container systems

FDA Recall Z-1698-2011 · Posted 2011-03-17

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2009-11-30
Date Terminated2011-03-18
Product Quantity874

Reason for Recall

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

Firm Action

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 [email protected] 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

Distribution Pattern

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 countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030513CELL-DYN 1800 SYSTEMAbbott Laboratories · 2003-05-12K991142CELL-DYN 1200 SYSTEMAbbott Laboratories · 1999-06-23K980614ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMSAbbott Laboratories · 1998-04-24K972354ABBOTT CELL-DYN 3200 SYSTEMAbbott Laboratories · 1997-09-16K951496CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZERAbbott Laboratories · 1995-10-19K870233CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZERAbbott Diagnostics · 1987-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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