25
Apr
2000

Inc ClassIII Abbott Laboratories

0

PRODUCT

Architect i 2000 System. Recall #Z-906-0.

REASON

System allows running of samples while the automatic flushing/cleaning
occurs.

CODE

All units, all software versions.

MANUFACTURER

Abbott Laboratories, Inc., Irving, Texas.

RECALLED BY

Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25,
2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide, Puerto Rico, Korea, Mexico, Canada, Germany, Japan,
Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Australia, New Zealand.

QUANTITY

603 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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