Z-0265-05

Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer

Name: Z-0265-05 Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer
Creator: Beckman Coulter Inc
Published: 2004-11-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-11-08 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer on 2004-11-08. The reason FDA records is "A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0265-05
Status: Terminated
Initiated: 2004-11-08
Posted: 2004-11-30
Terminated: 2012-08-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.
Root cause tag: software
FDA root cause: Other
Action: Product Corrective Action (PCA) letter that informs customers (who ordered Access Chlamydia reagent in the past 24 months and have an Access 2 Immunoassay System) of this potential issue sent via US mail on November 8, 2004. The letter instructs customers to use unique Sample IDs for all samples assayed on the system - including those which have been manipulated offline prior to assay. A Technical Information Update will be issued to inform all support personnel of this issue.
Quantity in commerce: 1,197
Distribution: Nationwide and Canada
Product codes and lots: Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.

Product code CGN

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)