Class III — Lin-Zhi International Inc
| Recalling firm | LIN-ZHI INTERNATIONAL, INC. |
|---|---|
| Registered facility | LIN-ZHI INTERNATIONAL, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Product | 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-… |
| Quantity | 60 items |
| Distribution | US Distribution in CA. |
| Initiated | 2013-10-03 |
| Classified | 2013-11-25 |
| Terminated | 2013-12-26 |
| Recall number | Z-0386-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Lin-Zhi International Inc (Z-0386-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66542/
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