The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2053-2013·Announced 2013-09-04

Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

Sarken, Inc. is recalling STAT! 1-Panel Test Kits 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, but the source text describes a labeling defect that could lead to misuse and incorrect results without reporting specific injuries, hospitalizations, or deaths. This aligns with the 'Moderate' criteria for labeling errors and low-risk contamination where no direct physical harm is reported.

Plain-English summary

Sarken, Inc. is recalling the SARKEN STAT! 1-Panel Test Kit-OPI. The product is labeled for forensic use only, specifically for employee, student, or probation testing. The recall involves various quantities of the test kits, identified by Manufacturer's Product Number DOP-114, Lot Number OPI2100003, and an expiration date of 09/2014.

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 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 U.S. Virgin Islands. Users of these test kits should stop using them and contact Sarken, Inc. for further instructions or a return.

The recalled product

Product
SARKEN STAT! 1- Panel Test Kit-OPI 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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