Reported Dec 4, 2013 · Terminated
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2…
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 Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C
- ContentsContains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative
- ManufacturerLin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine
- Lot codes and dates
Catalog #A68825Lot #1307086Exp. 3/28/2014/
- Amount recalled
- 60 items
Where it was sold
Why it was recalled
Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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