The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2048-2013·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 that the hazard is theoretical (potential for misuse and incorrect results) and does not report any illnesses, injuries, or deaths. Per the rubric, a theoretical hazard with no reported harm is capped at a score of 3, but given the nature of a labeling defect without immediate physical danger, it aligns with Moderate severity.

Plain-English summary

Sarken, Inc. is recalling the SARKEN STAT! Multi-Drug Test Panel. The product is labeled as "FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)". The recall involves various quantities of the product, specifically Manufacturer's Product Number HMO-W264, Lot Number F2290966, with an expiration date of 02/2014.

The products are being recalled because they were distributed without adequate labeling and instructions for use. The FDA notes that inadequate labeling could lead to misuse of the test kits and incorrect test results.

The product was distributed worldwide and nationwide in the United States, including the Virgin Islands. Consumers and users should stop using the affected test panels and contact Sarken, Inc. for further instructions or a refund.

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 Kits
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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