Retiro De Equipo (Recall) de Device Recall Abbott Molecular

Recall

69300

Class 2

Z-0948-2015

2013-11-23

2015-01-09

Terminated

United States

2017-12-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130190

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.

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.