FDA Medical Device Recalls (openFDA)
Abbott Molecular: The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
- Recall number
- Z-0948-2015
- Recalling firm
- Abbott Molecular
- Product
- The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
- Status
- Terminated
- Initiated
- 2013-11-23
- Posted
- 2015-01-09
- Terminated
- 2017-12-04
- Reason
- The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
- Root cause
- Nonconforming Material/Component
- Action
- Abbott Molecular sent a different Field Correction Recall / Urgent Field Safety Notice letters dated October 24, 2014 to each of three sets of customers. Customers whose instruments' X-Drive Assembly belts were perviously inspected by a Field Service Representative and found to not require replacement were advised to contact their local Abbott Molecular Representative or Abbott Molecular Technical Support at 800-553-7042 x 2 should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa. Customers whose instruments' X-Drive Assembly belts were previously inspected and replaced by a Field Service Representative were notifieied that this maintenance activity took place. Customers with questions were instructed to contact Abbott Molelcular. For questions regarding this recall call 224-361-7000. Customers whose instruments' X-Drive Assembly belts have not been inspected were notified that a Field Service Representative is scheduled to visit their facility to inspect and if necessary, replace the X-Drive Assembly belt(s). Customers were advised to contact their local Abbott Molecular Representative should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa.
- Quantity
- 176 devices
- Distribution
- Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
- Lot, serial or model codes
- List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416
- 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