Lin-Zhi International Inc: Medical Device Recall in 2019 - (Recall #: Z-1256-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: January 11, 2019

Date Posted: May 8, 2019

Recall Number: Z-1256-2019

Event ID: 82011

Reason for Recall:

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

Status: Terminated

Product Quantity: 49 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated