Z-0306-2009

CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated...

Name: Z-0306-2009 CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated...
Creator: Abbott Laboratories
Published: 2008-08-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-08-25 / Terminated / root cause: design

FDA source

Abbott Laboratories began a recall of CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use... on 2008-08-25. The reason FDA records is "Exposed wire resulted in minor electrical shock and burn to the service technician". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0306-2009
Status: Terminated
Initiated: 2008-08-25
Posted: 2008-11-21
Terminated: 2011-01-06
Recalling firm: Abbott Medical
Product: CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.
Product code: GKZ Counter, Differential Cell
Reason for recall: Exposed wire resulted in minor electrical shock and burn to the service technician
Root cause tag: design
FDA root cause: Device Design
Action: Recall issued August 22, 2008. Technical service bulletin was issued for all field personnel via internal database. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area.
Quantity in commerce: 958 units
Distribution: Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.
Product codes and lots: All pre production units with Serial numbers S-001 to S-026 and all production units with serial numbers 42003AZ-42007AZ, 42010AZ-42030AZ, 42032AZ-42033AZ, 42037AZ-42059AZ, 42061AZ-42062AZ, 42064AZ-42067AZ, 42072AZ-42074AZ, 42076AZ-42081AZ, 42083AZ-42123AZ, 42125AZ-42852AZ, 42854AZ-42944AZ, 42946AZ-42949AZ, 42951AZ, 42953AZ, 42955AZ-42961AZ, and 42963AZ-42964AZ

Product code GKZ

K051215Class IICell-Dyn Sapphire SystemAbbott Laboratories / cleared 2005-07-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)