Z-0639-2007

CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott...

Name: Z-0639-2007 CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott...
Creator: Abbott Laboratories
Published: 2004-05-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-05-12 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa... on 2004-05-12. The reason FDA records is "Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 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-0639-2007
Status: Terminated
Initiated: 2004-05-12
Posted: 2007-03-16
Terminated: 2007-05-01
Recalling firm: Abbott Medical
Product: CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Product code: GIF Diluent, Blood Cell
Reason for recall: Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
FDA root cause: Other
Action: On May 12, 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: 6,893 units
Distribution: Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.
Product codes and lots: Lot Numbers: 14454I2, 14455I2, 14456I2, 14457I2, 15611I2

Product code GIF

K961439Class IIAbbott Cell-Dyn 4000 SystemAbbott Diagnostics / cleared 1996-10-18

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)