Company: Abbott Laboratories
Date of Enforcement Report 10/1/2008
Class:ll
PRODUCT
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01; v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations, Recall # Z-2231-2008
REASON
Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on May 23, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,378 units
DISTRIBUTION
Nationwide and Internationally
