CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL… recallZ-2016-2011 · Abbott Laboratories · initiated Mar 15, 2011
Terminated All recalls posted in April 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 Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
FDA root cause category: Pending
What the company is doing
Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
Recall details
- Recall number
- Z-2016-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 15, 2011
- Posted by the FDA
- Apr 29, 2011
- Recalling firm
- Abbott Laboratories
- Quantity
- 174 instruments total, all varieties
- Product code
- GKZ
- FDA submissions
- K991605
- Distribution
- Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
Product description
CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
Code information (models, lots, serial numbers)
List Number 91350-01; lot numbers: 31222P, 32091P Refurbished list number: 91350-03; lot number: 32159P96
Other devices under the same FDA submission
3 devices cleared under K991605 — 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 02H31-01Abbott Laboratories · Counter, differential cell4 reports
- CELL-DYN 02H31-03Abbott Laboratories · Counter, differential cell3 reports
- CELL-DYN 02H30-01Abbott Laboratories · Counter, differential cell2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 58188).
- Z-2014-2011 · TerminatedCELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro dia…
- Z-2015-2011 · TerminatedCELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro dia…
- Z-2020-2011 · TerminatedCELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054
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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