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 | Shelf life of the product may be reduced due to degradation of the assay. |
| Product | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot. |
| Quantity | 49 kits |
| Distribution | US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR |
| Initiated | 2019-01-11 |
| Classified | 2019-05-02 |
| Terminated | 2021-03-22 |
| Recall number | Z-1256-2019 |
| 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-1256-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82011/
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.