Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2013-10-03 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0386-2014
Date of alert: 2013-10-03
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Lin-Zhi International Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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