Abbott Architect I Class II 173 units

All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9.

REASON

The device may report incorrect results for diluted samples;
and/or when used with the Laboratory Information System or Host
Information Systems, the system may incorrectly associate test
results with patient ID or incorrectly associate control results
with patient records.

CODE

List #08C89-00-01.

MANUFACTURER

Abbott Laboratories, Irving, Texas.

RECALLED BY

Manufacturer, by letter and telephone on April 12, 1999. Firm-initiated
recall ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

173 units were distributed.

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

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IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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