Recall Z-1256-2019— Lin-Zhi International Inc

Name: FDA recall Z-1256-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-11

Class III · Terminated

Class III FDA medical device recall by Lin-Zhi International Inc, initiated 2019-01-11, terminated 2021-03-22. It names one FDA 510(k) clearance: K032461. 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.. Reason: Shelf life of the product may be reduced due to degradation of the assay..

Recalling firm: Lin-Zhi International Inc
Classification: Class III
Status: Terminated
Initiated: 2019-01-11
Terminated: 2021-03-22
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K032461 — ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc.·cleared 2003-10-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.