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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Molecular Abbott m2000sp

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  Class 2 Device Recall Abbott Molecular Abbott m2000sp see related information
Date Initiated by Firm October 23, 2014
Date Posted November 25, 2014
Recall Status1 Terminated 3 on March 08, 2016
Recall Number Z-0463-2015
Recall Event ID 69542
510(K)Number K092705  
Product Classification Clinical sample concentrator - Product Code JJH
Product Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Code Information List Number: 09K14; Models: E series, G series
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Technical Support
800-553-7042 Ext. 2
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Field Correction Recall / Urgent Field Safety Notice letters dated September 23, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) review the app spec files that are installed on the m2000sp system and delete any incompatible app specs; 2) if one or more app spec files were deleted, installation of new app spec file(s) is needed; and, 3) review this information with laboratory personnel and retain the letter for future reference. Customers with questions about this market action can contact Technical Support at 800-553-7042, Option 2, or the local Abbott Molecular representative.
Quantity in Commerce 9 CD ROMs (US); 1,273 CD ROMs (Foreign)
Distribution Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJH and Original Applicant = ABBOTT MOLECULAR, INC.
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