The Waste Line Assembly and the Waste Outlet Tubing and the… recallZ-1698-2011 · Abbott Laboratories · initiated Nov 30, 2009
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The use of the device assemblies has been extended to a 6 month useful life.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1698-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 30, 2009
- Posted by the FDA
- Mar 17, 2011
- Recalling firm
- Abbott Laboratories
- Quantity
- 874
- Product code
- GKZ
- FDA submissions
- K030513, K870233, K951496, K972354, K980614, K991142
- 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.
Product description
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
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K030513, K870233, K951496, K972354, K980614, K991142 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CELL-DYN 07H77-01Abbott Laboratories · Counter, differential cell8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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