FDAFDA · Food and drugs·Recall number Z-1270-2014
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
Published April 2, 2014 · Recall initiated: February 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Lin-Zhi International Inc
- Distributor
- US Distribution including CA.
- Lot
- Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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