Z-0451-2007

Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX

Name: Z-0451-2007 Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX
Creator: Drew Scientific Group PLC
Published: 2006-09-20
License: https://open.fda.gov/license/

JAS Diagnostics/Drew Scientific / initiated 2006-09-20 / Terminated

FDA source

Drew Scientific Group PLC began a recall of Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX on 2006-09-20. The reason FDA records is "System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0451-2007
Status: Terminated
Initiated: 2006-09-20
Posted: 2007-01-05
Terminated: 2008-03-10
Recalling firm: JAS Diagnostics/Drew Scientific
Product: Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
Product code: GKZ Counter, Differential Cell
Reason for recall: System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
FDA root cause: Other
Action: Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.
Quantity in commerce: 299 units.
Distribution: Worldwide distribution ---- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.
Product codes and lots: All lots.

Product code GKZ

K991539Class IIExcell 22Mwi, Inc. / cleared 1999-07-01

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)