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 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.
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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