FDA recall Z-1256-2019

Lin-Zhi International Inc · Class III · device

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-01-11
Report date
2019-05-08
Termination date
2021-03-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2019