Reported Apr 25, 2018 · Terminated

Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

OraSure Technologies, 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: OraSure Technologies, Inc. · 1745 Eaton Ave · Bethlehem, PA · 18018-1769

Is this the product you have?

  • Cocaine Metabolite MICRO-PLATE EIA
  • Catalog Number1122SC
  • UDI(0100608337000429(17)180228(10)000
Lot codes and dates
  • Lot Number0006661251
  • Expiration date02/28/2018
Amount recalled
10

Where it was sold

Why it was recalled

The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

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 Apr 2, 2020 · Data as of Sep 19, 5:32 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.