FDA Medical Device Recalls (openFDA)
Abbott Molecular: Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
- Recall number
- Z-0365-2012
- Recalling firm
- Abbott Molecular
- 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
- Status
- Terminated
- Initiated
- 2011-10-11
- Posted
- 2012-01-11
- Terminated
- 2016-02-23
- Reason
- Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
- Root cause
- 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
- 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
- Lot, serial or model codes
- list 09K14, all serial numbers
- 510(k) numbers
- ["K092705"]
- PMA numbers
- not on file
- Product code
- JJH
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28