Epigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs
Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit because the diagnostic test may produce invalid runs, potentially delaying 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. The hazard involves delayed test results due to invalid runs, which is a functional defect without reported injuries or hospitalizations, fitting the Moderate severity criteria for low-risk issues or voluntary precautionary recalls.
Plain-English summary
Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit (Catalog Number M5-02-001). The recall is limited to Lot Number 16903908, which has an expiration date of February 28, 2018.
The recall was initiated because the diagnostic test kit may produce invalid test runs. This issue may delay the availability of test results for patients.
The affected units were shipped to one U.S. distributor in New York and further distributed in nine states: California, Michigan, North Carolina, Nebraska, New Jersey, Pennsylvania, Tennessee, Texas, and Utah. Consumers and healthcare providers should stop using the affected kits and contact Epigenomics Ag for instructions on how to return the product.
The recalled product
- Product
- Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
- Manufacturer
- Epigenomics Ag
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 16903908
- Expiration Date: 28 Feb 2018
Distribution
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