The Recall Desk
ModerateFDA (Devices)·Z-1408-2014·Announced 2014-04-16

LumiQuick K2 Synthetic Marijuana Test Card Recalled for Regulatory Violations

LumiQuick Diagnostics is recalling K2 Test Cards because they were shipped to locations without required FDA clearances.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a regulatory compliance issue (unauthorized distribution) rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for minor labeling or compliance errors.

Plain-English summary

LumiQuick Diagnostics Inc. is recalling K2 (synthetic Marijuana) Test Cards, catalog number 74066. The recall covers all lots of the product. The company is based in Santa Clara, California.

The recall was initiated because the products were shipped to US locations that do not have approved applications for Premarket Approval (PMA), Investigational Device Exemption (IDE), or 510(k) clearance. This constitutes a regulatory violation regarding the distribution of medical devices.

The affected products were distributed in the states of California, Florida, New Jersey, Texas, and New York. Consumers who possess these test cards should stop using them and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog number: 74066
  • All lots

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 80 recalled by LumiQuick Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 80 products in this recall →

Same manufacturer · LumiQuick Diagnostics Inc.

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