Company:Abbott Laboratories, Inc
Date of Enforcement Report 6/15//2010
Class:ll
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. Recall # Z-1316-2010
REASON
ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 11, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
104 units
DISTRIBUTION
Nationwide and Internationally
