18
May
1999

Abbott Alcyon Analyzers Class II 55 units

0

Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.Recall #Z-267-0.

REASON

The device may give incorrect tests results or reference ranges
when printing the “Complete Report (header)”, “Incomplete Report
(DRAFT)”, and the “Control Results printout.”

CODE

List #4E73-04.

MANUFACTURER

Abbott Laboratories, Inc., Irving, Texas.

RECALLED BY

Manufacturer, by telephone on May 18 and 19, 1999, followed by
letter dated May 18, 1999. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Japan.

QUANTITY

55 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.

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