Z-0565-2007

CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01...

Name: Z-0565-2007 CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01...
Creator: Abbott Laboratories
Published: 2006-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-22 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers on 2006-12-22. The reason FDA records is "Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0565-2007
Status: Terminated
Initiated: 2006-12-22
Posted: 2007-03-01
Terminated: 2007-11-28
Recalling firm: Abbott Medical
Product: CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
Product code: GIF Diluent, Blood Cell
Reason for recall: Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
FDA root cause: Other
Action: Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
Quantity in commerce: 652 (20 L. each) cubitainers
Distribution: Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
Product codes and lots: Lot Number 42063I2, List Number 01H73-01

Product code GIF

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)