Reported May 8, 2019 · Terminated

Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent…

Lin-Zhi International Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lin-Zhi International Inc · 2945 Oakmead Village Ct · Santa Clara, CA · 95051-0812

Is this the product you have?

  • Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b)
  • REF 0221 (large test kit) Product UsageDetergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot
Lot codes and dates
  • (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025
Amount recalled
49 kits

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2021 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.