The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2049-2013·Announced 2013-09-04

Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test 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, but the source text explicitly states the hazard is inadequate labeling leading to potential misuse and incorrect results, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination where harm is theoretical.

Plain-English summary

Sarken, Inc. is recalling the SARKEN STAT! Multi-Drug Test Panel. The product is 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 creates a risk that the test kits may be misused, which could result in incorrect test results. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

The affected products were distributed worldwide and nationwide in the United States, including the Virgin Islands. Various quantities of the product were involved. Specific lot numbers and expiration dates are listed in the structured product information. Consumers and businesses should stop using the affected test panels and contact the recalling firm for further instructions.

The recalled product

Product
SARKEN STAT! Multi-Drug Test Panel 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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