Z-1199-2007

Abbott CELL-DYN 3500 Hematology Analyzer

Name: Z-1199-2007 Abbott CELL-DYN 3500 Hematology Analyzer
Creator: Abbott Laboratories
Published: 2007-05-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-05-11 / Terminated

FDA source

Abbott Laboratories began a recall of Abbott CELL-DYN 3500 Hematology Analyzer on 2007-05-11. The reason FDA records is "The product failed electrostatic discharge testing, which could result in product failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1199-2007
Status: Terminated
Initiated: 2007-05-11
Posted: 2007-08-29
Terminated: 2008-06-19
Recalling firm: Abbott Medical
Product: Abbott CELL-DYN 3500 Hematology Analyzer
Product code: GKZ Counter, Differential Cell
Reason for recall: The product failed electrostatic discharge testing, which could result in product failure.
FDA root cause: Other
Action: Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.
Quantity in commerce: 3,429 units, all models
Distribution: Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.
Product codes and lots: Model number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, all serial numbers distributed before May 3, 2007. Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03, all serial numbers distributed on or before May 3, 2007: 91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000

Product code GKZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)