The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2050-2013·Announced 2013-09-04

Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions

Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to inadequate labeling leading to potential misuse and incorrect results, which aligns with the rubric for moderate severity involving labeling errors without reported injuries.

Plain-English summary

Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC. These products are labeled for forensic use only, specifically for employee, student, or probation testing. The recall is due to the products being distributed without adequate labeling and instructions for use.

The inadequate labeling could lead to the misuse of the test kits and result in incorrect test outcomes. The affected products were distributed worldwide and nationwide in the United States, including the Virgin Islands. Specific lot numbers and expiration dates are listed in the official recall record.

Consumers and distributors should stop using these test kits and contact Sarken, Inc. for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences or a remote probability of serious adverse health consequences.

The recalled product

Product
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Manufacturer
Sarken, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Sarken, 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 6 products in this recall →

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