Abbott Laboratories, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Laboratories, Inc is recalling ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 due to ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026