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Terminated

Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14

FDA Recall Z-0365-2012 · Posted 2012-01-11

Recalling FirmAbbott Molecular
Recall StatusTerminated
Product CodeJJH
Date Initiated2011-10-11
Date Terminated2016-02-23
Product Quantity432 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501Abbott Molecular, Inc. · 2010-05-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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