Oct

2008

Abbott Lab ARCHITECT c8000 Cl Il

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Abbott Lab ARCHITECT c8000 Cl Il

Amy Sellers

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