Z-1256-2019Class III

Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit)

Name: Z-1256-2019 Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit)
Creator: Lin-Zhi International Inc
Published: 2019-01-11
License: https://open.fda.gov/license/

Lin-Zhi International Inc / initiated 2019-01-11 / Terminated / root cause: manufacturing process

FDA source

Lin-Zhi International Inc began a recall of 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... on 2019-01-11. FDA classified it as Class III and gives the reason as "Shelf life of the product may be reduced due to degradation of the assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1256-2019
Classification: Class III
Status: Terminated
Initiated: 2019-01-11
Posted: 2019-05-03
Terminated: 2021-03-22
Recalling firm: Lin-Zhi International Inc
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.
Product code: DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Reason for recall: Shelf life of the product may be reduced due to degradation of the assay.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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]
Quantity in commerce: 49 kits
Distribution: US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Product codes and lots: (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1256-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1256-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code DIC

K032461Class IIEthyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc. / cleared 2003-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)