Cl Il ARCHITECT System Software v5.00 and v5.10

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

About the author

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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