Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator 의 리콜

Recall

67607

Class 3

Z-1270-2014

2014-02-18

2014-03-21

Terminated

United States

2014-04-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125829

Customer reported that the synchron nbup cutoff calibrator (10 ng/ml) could not be qualified through quality control testing. the cutoff calibrator was recovering at a concentration close to the nbup control level 1 (7 ng/ml).

Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.