Recall Z-1256-2019 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Lin-Zhi International Inc
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.
| Date | Jan 11, 2019 |
| Status | Terminated |
| Reason | Shelf life of the product may be reduced due to degradation of the assay. |
| Root cause | Material/Component Contamination |
| Action | Lin-Zhi International initiated the recall by email to its distributors on 01/11/2019. The letter identified the affected product, problem and actions to be taken. The distributors were directed to notify their customers and requested the destruction of the recalled product. For questions call T: ( 408) 970-8811 E: regulatory@lin-zhi.com |
| Quantity | 49 kits |
| Distribution | US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc., Oct 3, 2003 |