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 | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). |
| Product | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer |
| Quantity | 120 units, 60 of each lot number |
| Distribution | US Distribution including CA. |
| Initiated | 2014-02-18 |
| Classified | 2014-03-21 |
| Terminated | 2014-04-25 |
| Recall number | Z-1270-2014 |
| 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-1270-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67607/
Alerts for LIN-ZHI INTERNATIONAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.