The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2051-2013·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 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 hazard is limited to inadequate labeling leading to potential misuse and incorrect results, without reports of injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

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

The inadequate labeling creates a risk of misuse of the test kits, which could result in incorrect test results. The affected products include various quantities distributed worldwide and nationwide in the US Virgin Islands. Specific lot numbers COC2010004 and COC2110076 are involved, with expiration dates of 12/2013 and 09/2014.

Consumers and distributors should stop using these test kits and contact Sarken, Inc. for further instructions or a refund.

The recalled product

Product
SARKEN STAT! 1- Panel Test Kit-COC 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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