FDA-Device2019-05-08Class III
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.
Lin-Zhi International Inc
Hazard
Shelf life of the product may be reduced due to degradation of the assay.
Sold states
US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Affected count
49 kits
Manufactured in
2945 Oakmead Village Ct, N/A, Santa Clara, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2019Don't want to check this manually?
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