Skip to content
Recall Observatory FDA recall evidence

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.

Z-1256-2019

January 11, 2019

Class III

Product summary

Firm
Lin-Zhi International Inc
Event
Event 82011
Status
Terminated
Classification
Class III
Quantity
49 kits
Official record key
device-enforcement:Z-1256-2019

Official wording

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

Code information: (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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