Z-0692-03

Access 2 Immunoassay System

Name: Z-0692-03 Access 2 Immunoassay System
Creator: Beckman Coulter Inc
Published: 2003-01-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-01-30 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access 2 Immunoassay System on 2003-01-30. The reason FDA records is "False results from secondary pour off tubes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0692-03
Status: Terminated
Initiated: 2003-01-30
Posted: 2003-03-29
Terminated: 2004-06-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System
Reason for recall: False results from secondary pour off tubes
FDA root cause: Other
Action: Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.
Quantity in commerce: 718
Distribution: Nationwide and Canada
Product codes and lots: All fielded instruments.

K922823Class IIAccess Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. / cleared 1992-08-05

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)