Feb

2000

Abbott Aeroset IVD Assay Disks Class II

2/24/00 Class II

PRODUCT

Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette
to upgrade the Aeroset System, which is a clinical chemistry analyzer,
used for in-vitro diagnostic tests. Recall #Z-488-0.

REASON

The disks are improperly duplicated and contain software that will
install System International (SI) units, rather than conventional
units as labeled.

CODE

List #4E43-03, distributed between 2/8/00 and 2/12/00.

MANUFACTURER

Abbott Laboratories, Inc., Irving, Texas.

Vendor, Media Magnetics, Richardson, Texas (the firm that duplicated
the disks).

RECALLED BY

Abbott Laboratories, Inc., Irving, Texas, by telephone on February 24,
2000. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Brazil.

QUANTITY

97 units were distributed.

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 Aeroset IVD Assay Disks Class II

Amy Sellers

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