Dec

2014

Cl II Abbott m2000sp

Company: Abbott Molecular.
Date of Enforcement Report 12/3/2014
Class lI:

PRODUCT

Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing. Recall Number Z-0463-2015

REASON
Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause Error Code 9000 (“An unexpected error has occurred: Software error”) to generated when screen is selected.

RECALLING FIRM/MANUFACTURER
Abbott Molecular, Des Plaines IL 10/23/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 CD ROMs (US); 1,273 CD ROMs (Foreign)

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Cl II Abbott m2000sp

Amy Sellers

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