FDA Device recall Z-1256-2019
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradat…
- FDA Device
- Class III
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class III recall of Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradat… by Lin Zhi International, citing shelf life of the product may be reduced due to degradation of the assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1256-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-11 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Lin Zhi International |
| Distribution | US |
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
Shelf life of the product may be reduced due to degradation of the assay.
Identifiers
| code_info | (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1256-2019%22
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