Device Recall Roche Molecular Systems cobas 4800 System 의 리콜

Recall

64453

Class 2

Z-1028-2013

2013-03-01

2013-04-01

Terminated

United States

2014-06-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116170

Certain lots of reagent reservoirs, may not have a separation in the lower part of the reservoir. as a consequence, pipetting errors can occur due to uneven distribution of reagent. these pipetting errors may lead to delayed results and wasted reagent.

Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.