Z-0571-03

Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter

Name: Z-0571-03 Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
Creator: Beckman Coulter Inc
Published: 2002-12-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2002-12-10 / Terminated / root cause: design

FDA source

Beckman Coulter Inc began a recall of Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter on 2002-12-10. The reason FDA records is "Device design allows for cross contamination issue to occur, possibly affecting assays and results reports". 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-0571-03
Status: Terminated
Initiated: 2002-12-10
Posted: 2003-02-25
Terminated: 2004-04-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
Reason for recall: Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
Root cause tag: design
FDA root cause: Other
Action: Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
Quantity in commerce: 447
Distribution: Nationwide and Canada
Product codes and lots: In the LH 700 series, all serial numbers up to AE1088. In the GENS series, all instruments.

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)