Z-0706-2007

CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott...

Name: Z-0706-2007 CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott...
Creator: Abbott Laboratories
Published: 2004-09-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-09-29 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara... on 2004-09-29. The reason FDA records is "Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0706-2007
Status: Terminated
Initiated: 2004-09-29
Posted: 2007-04-03
Terminated: 2007-05-01
Recalling firm: Abbott Medical
Product: CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Product code: GIF Diluent, Blood Cell
Reason for recall: Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
FDA root cause: Other
Action: On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.
Quantity in commerce: 27,411 units
Distribution: Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.
Product codes and lots: Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2

Product code GIF

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