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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott m2000sp Instrument

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  Class 2 Device Recall Abbott m2000sp Instrument see related information
Date Initiated by Firm October 11, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 23, 2016
Recall Number Z-0365-2012
Recall Event ID 60117
510(K)Number K092705  
Product Classification Clinical sample concentrator - Product Code JJH
Product Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
Code Information list 09K14, all serial numbers
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact
224-361-7133
Manufacturer Reason
for Recall		 Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
FDA Determined
Cause 2		 Component design/selection
Action Abbott Molecular sent a Field Correction Recall letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until further notice, and to complete the enclosed reply sheet and fax it to (847) 775-6728 at their earliest convenience to acknowledge receipt and understanding of the letter. For questions regarding this recall call 224-361-7133.
Quantity in Commerce 432 units
Distribution Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Australia, Austria, Azerbaijan, Belgium, Brazil, Burundi, Cameroon, China, Croatia, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Germany, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Libya, Malawi, Malaysia, Mali, Mozambique, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Vietnam and Zambia
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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