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
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
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