Device product
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
Z-1270-2014
Product summary
- Event
- Event 67607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 120 units, 60 of each lot number
- Official record key
device-enforcement:Z-1270-2014
Official wording
Reason: 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).
Code information: Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
Distribution pattern: US Distribution including CA.
Derived failure modes
-
Unknown
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).