28
Apr
2004

Inc. Class II Abbott Laboratories

0

Company: Abbott Laboratories, Inc.
Date of Enforcement Report: 4/28/04
Class: II

PRODUCT
ARCHTECT System RS-232 Manual, product list number 06F71-
04, for the ARCHITECT i2000 Processing Module and the
ARCHITECT C8000 Processing Module. Recall # Z-0818-04.

REASON
When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.

CODE
The RS-232 Manual is not controlled by control or lot numbers.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on March 23, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
101.

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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