Z-2018-2011

CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott...

Name: Z-2018-2011 CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott...
Creator: Abbott Laboratories
Published: 2011-03-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-03-15 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054... on 2011-03-15. The reason FDA records is "The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2018-2011
Status: Terminated
Initiated: 2011-03-15
Posted: 2011-04-29
Terminated: 2011-11-22
Recalling firm: Abbott Medical
Product: CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
FDA root cause: Pending
Action: 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.
Quantity in commerce: 174 total units, all varieties
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 codes and lots: List Number 04H60-01; lot number: 61401AF, 61686AF, 61705AF, 62201AF, 62634AF, and 62469AF; Refurbished list number: 04H60-03; lot numbers: 62418AF96, and 60311AF96.

Product code GKZ

K972354Class IIAbbott Cell-Dyn 3200 SystemAbbott Laboratories / cleared 1997-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)