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.
FDA Recall Z-1256-2019 · Posted None
Advertisement
Recalling FirmLin-Zhi International Inc
Recall StatusTerminated
Product CodeDIC
Date Initiated2019-01-11
Date Terminated2021-03-22
Product Quantity49 kits
Reason for Recall
Shelf life of the product may be reduced due to degradation of the assay.
Firm 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: [email protected]
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement