Z-1071-03

Coulter Clone B6-FITC Reagent

Name: Z-1071-03 Coulter Clone B6-FITC Reagent
Creator: Beckman Coulter Inc
Published: 2003-04-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-04-28 / Terminated

FDA source

Beckman Coulter Inc began a recall of Coulter Clone B6-FITC Reagent on 2003-04-28. The reason FDA records is "Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1071-03
Status: Terminated
Initiated: 2003-04-28
Posted: 2003-07-30
Terminated: 2004-04-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter Clone B6-FITC Reagent
Reason for recall: Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has shown a diminished expression on B-Cell populations when drawn on EDTA tubes, which may lead to inaccurate interpretation of phenotype results.
FDA root cause: Other
Action: Customer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.
Quantity in commerce: 122
Distribution: Nationwide and to Canada
Product codes and lots: Lots 735512F, 735513F and 735514FR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)