Lin-Zhi International Inc recalls Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent ca…

Recall date

January 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1256-2019

FDA classification

Class III

Brand / firm

Lin-Zhi International Inc

Sold / distributed

US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR

Why it was recalled

Shelf life of the product may be reduced due to degradation of the assay.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.