Z-1316-2010

ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and...

Name: Z-1316-2010 ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and...
Creator: Abbott Laboratories, Inc
Published: 2009-09-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-09-11 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part... on 2009-09-11. The reason FDA records is "ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters". 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-1316-2010
Status: Terminated
Initiated: 2009-09-11
Posted: 2010-04-09
Terminated: 2011-01-25
Recalling firm: Abbott Medical
Product: ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
Root cause tag: software
FDA root cause: Software design
Action: Technical Service Bulletins dated September 11, 2009 were issued to affected consignees. The correction was issued via the Technical Service Bulletins (TSB) to provide a software patch to re-establish the correct parameters on the LLS board. Direct questions to Abbott Laboratories, Inc. by calling 1-972-518-6000.
Quantity in commerce: 11 in the USA; 104 worldwide
Distribution: Worldwide.
Product codes and lots: List numbers 5F48-22 and 5F48-23, part numbers 7-204717-01 and 7-204717-02 when used with 7-94255-01 and 7-200788-01.

Product code JJE

K983212Class IAbbott Architect TestosteroneAbbott Laboratories / cleared 1998-11-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)