Z-0576-05

Access Immunoasay Systems Digoxin Reagent

Name: Z-0576-05 Access Immunoasay Systems Digoxin Reagent
Creator: Beckman Coulter Inc
Published: 2005-02-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-02-23 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access Immunoasay Systems Digoxin Reagent on 2005-02-23. The reason FDA records is "Variability in results on Patient and QC results of 20-25%, high and low". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0576-05
Status: Terminated
Initiated: 2005-02-23
Posted: 2005-03-08
Terminated: 2005-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoasay Systems Digoxin Reagent
Product code: KXT Enzyme Immunoassay, Digoxin
Reason for recall: Variability in results on Patient and QC results of 20-25%, high and low.
FDA root cause: Other
Action: Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.
Quantity in commerce: 4352 domestically.
Distribution: Nationwide and Canada
Product codes and lots: Lots 323171; 416110; 417703; 419534

Product code KXT

K925802Class IIAccess Digoxin AssayBio-Rad Laboratories, Inc. / cleared 1993-01-13

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)