FDAFDA · Food and drugs·Recall number Z-0386-2014
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-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.
Published December 4, 2013 · Recall initiated: October 3, 2013
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lin-Zhi International Inc
- Distributor
- US Distribution in CA.
- Lot
- Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.