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.
What this means for you
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 error that could lead to incorrect results rather than direct physical injury or hospitalization, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Sarken, Inc. is recalling the SARKEN STAT! 1-Panel Test Kit-mAMP. 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 could lead to misuse of the test kits and result in incorrect test outcomes. The affected units are identified by Manufacturer's Product Number DMA-114, Lot Number MET2100027, and an expiration date of 08/2014. The products were distributed worldwide and nationwide in the United States, including the Virgin Islands.
Consumers and distributors should stop using the affected test kits and contact Sarken, Inc. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
- Manufacturer
- Sarken, Inc.
Distribution
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 →Related recalls
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