Ethyl Alcohol Enzymatic Assay — Class III medical device recall Z-1256-2019
Terminated recall by Lin-Zhi International Inc, reported 2019-05-08, distributed nationwide. Shelf life of the product may be reduced due to degradation of the assay.
| Recall number | Z-1256-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lin-Zhi International Inc, Santa Clara, CA, United States |
| Recall initiated | 2019-01-11 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2021-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 49 kits |
| Reason classes | potency, specification failure |
| Lot numbers | 1810025, 1810026 |
| Model numbers | 0220, 0221 |
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.
Reason for recall
Shelf life of the product may be reduced due to degradation of the assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1256-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.