Z-1148-03

Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

Name: Z-1148-03 Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
Creator: Beckman Coulter Inc
Published: 2003-06-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-18 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29 on 2003-06-18. The reason FDA records is "Defective software media distributed with upgrade software may cause installation failure and systems lock". 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-1148-03
Status: Terminated
Initiated: 2003-06-18
Posted: 2003-08-21
Terminated: 2004-04-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
Product code: KLS Enzyme Immunoassay, Theophylline
Reason for recall: Defective software media distributed with upgrade software may cause installation failure and systems lock.
Root cause tag: software
FDA root cause: Other
Action: Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.
Quantity in commerce: 1615
Distribution: United States only, nationwide.
Product codes and lots: Software version 3.29

Product code KLS

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)