Recall Z-0948-2015 ยท JJH Clinical Sample Concentrator
Abbott Molecular
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
| Date | Jan 9, 2015 (initiated Nov 23, 2013) |
| Status | Terminated |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc., May 28, 2010 |