Reported Apr 29, 2020 · Terminated

Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

Carolina Liquid Chemistries Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Carolina Liquid Chemistries Corp · 510 W Central Ave Ste C · Brea, CA · 92821-3032

Is this the product you have?

  • Fentanyl Reagent Kit, Product N. CC444
  • ContainsFENT R1 Reagent and FENT R2 Reagent
Lot codes and dates
  • Lots
    • H1801
    • C1942
    • D1945
    • H1901
    • H1933
    • L1909
Amount recalled
90 test kits/devices

Where it was sold

Why it was recalled

Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 14, 2021 · Data as of Sep 19, 6:18 PM UTC

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