Reported Apr 2, 2014 · Terminated
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only;…
Lin-Zhi International Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lin-Zhi International Inc · 670 Almanor Ave · Sunnyvale, CA · 94085-3513
Is this the product you have?
- Single Analyte
- DAU Calibrator (5 mL) NorbuprenorphineCutoff 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
- Lot codes and dates
- Product catalog number
A68827Lots 13080061308131
- Expiry
March 282015
- Product catalog number
- Amount recalled
- 120 units, 60 of each lot number
Where it was sold
Why it was recalled
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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