Z-1270-2014 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2014
- Initiation Date
- February 18, 2014
- Termination Date
- April 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units, 60 of each lot number
Product Description
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Reason for Recall
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).
Distribution Pattern
US Distribution including CA.
Code Information
Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.