Z-0541-03

Coulter LH 700 Series Hematology Analyzers

Name: Z-0541-03 Coulter LH 700 Series Hematology Analyzers
Creator: Beckman Coulter Inc
Published: 2003-01-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-01-10 / Terminated

FDA source

Beckman Coulter Inc began a recall of Coulter LH 700 Series Hematology Analyzers on 2003-01-10. The reason FDA records is "Biohazard situation exists for users". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0541-03
Status: Terminated
Initiated: 2003-01-10
Posted: 2003-02-05
Terminated: 2003-07-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH 700 Series Hematology Analyzers
Product code: GKZ Counter, Differential Cell
Reason for recall: Biohazard situation exists for users.
FDA root cause: Other
Action: Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.
Quantity in commerce: 210
Distribution: Nationwide and Canada.
Product codes and lots: All lots.

Product code GKZ

K011342Class IICoulter Lh 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. / cleared 2001-07-09

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)