Z-0527-06

CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

Name: Z-0527-06 CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
Creator: Abbott Laboratories
Published: 2005-12-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-16 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer on 2005-12-16. The reason FDA records is "T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0527-06
Status: Terminated
Initiated: 2005-12-16
Posted: 2006-02-16
Terminated: 2006-04-13
Recalling firm: Abbott Medical
Product: CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
Product code: GKZ Counter, Differential Cell
Reason for recall: T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
FDA root cause: Other
Action: The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
Quantity in commerce: 871 units
Distribution: Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
Product codes and lots: List Number: 07H22-01, lot numbers: 16328 and 29401

Product code GKZ

K010953Class IICell-Dyn 4000 Immuno T-Cell (Cd3/4/8) AssayAbbott Laboratories / cleared 2001-06-06

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)