FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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
- Recall number
- Z-1698-2011
- Recalling firm
- Abbott Laboratories
- Product
- 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
- Status
- Terminated
- Initiated
- 2009-11-30
- Posted
- 2011-03-17
- Terminated
- 2011-03-18
- Reason
- The use of the device assemblies has been extended to a 6 month useful life.
- Root cause
- Other
- 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 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.
- Quantity
- 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 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.
- Lot, serial or model codes
- Model Numbers: 92161-02 and 06H54-01 for the Waste Line Assembly; 02H96-01 for the Waste Outlet Tubing; and 03H98-02 for the Waste Bottle Cable.
- 510(k) numbers
- ["K030513","K870233","K951496","K972354","K980614","K991142"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28