Z-0648-03

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

Name: Z-0648-03 Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
Creator: Abbott Laboratories
Published: 2002-10-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-10-16 / Terminated

FDA source

Abbott Laboratories began a recall of Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01 on 2002-10-16. The reason FDA records is "Product elicits fluorescent signal interference due to contamination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0648-03
Status: Terminated
Initiated: 2002-10-16
Posted: 2003-03-13
Terminated: 2003-08-21
Recalling firm: Abbott Medical
Product: Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
Product code: GKZ Counter, Differential Cell
Reason for recall: Product elicits fluorescent signal interference due to contamination.
FDA root cause: Other
Action: On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
Quantity in commerce: 1383 units
Distribution: Nationwide and Argentina, Canada and Puerto Rico.
Product codes and lots: Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)

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)