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Terminated

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.

FDA Recall Z-1316-2010 · Posted 2010-04-09

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2009-09-11
Date Terminated2011-01-25
Product Quantity11 in the USA; 104 worldwide

Reason for Recall

ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983212ABBOTT ARCHITECT TESTOSTERONEAbbott Laboratories · 1998-11-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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