Lin-Zhi International Inc: Medical Device Recall in 2013 - (Recall #: Z-0386-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: October 3, 2013

Date Posted: December 4, 2013

Recall Number: Z-0386-2014

Event ID: 66542

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.

Status: Terminated

Product Quantity: 60 items

Code Information:

Catalog #A68825, Lot #1307086; Exp. 3/28/2014/

Distribution Pattern:

US Distribution in CA.

Voluntary or Mandated:

Voluntary: Firm initiated