Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Single Analyte Urine DAU Control (5 m L Norbuprenorphine Recalled by Lin-Zhi International Inc Due to Product catalog # A68825 Norbuprenorphine 13 ng/mL Level...

Date: October 3, 2013
Company: Lin-Zhi International Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lin-Zhi International Inc directly.

Affected Products

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.

Quantity: 60 items

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Lin-Zhi International Inc

Lin-Zhi International Inc has 5 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report