Product Wiki · Recalls · U.S. FDA — Device Enforcement

Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. — recall Z-0463-2015

U.S. FDA — Device Enforcement · United States · 2014-10-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0463-2015
Date of alert
2014-10-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Molecular
Product category
device
Product type
Devices
Reported risk: Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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