FDA Medical Device Recalls (openFDA)
Lin-Zhi International Inc: 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.
- Recall number
- Z-1256-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-01-11
- Posted
- not on file
- Terminated
- 2021-03-22
- Reason
- Shelf life of the product may be reduced due to degradation of the assay.
- 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: regulatory@lin-zhi.com
- Quantity
- 49 kits
- Distribution
- US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
- Lot, serial or model codes
- (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025
- 510(k) numbers
- ["K032461"]
- PMA numbers
- not on file
- Product code
- DIC
- Firm FEI
- 3003610499
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28