Z-0386-2014 Class III Terminated
FDA device recall Z-0386-2014 was initiated by Lin-Zhi International Inc on October 3, 2013 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated December 26, 2013). Affected quantity: 60 items.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- October 3, 2013
- Termination Date
- December 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 items
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution in CA.
Code Information
Catalog #A68825, Lot #1307086; Exp. 3/28/2014/