Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance
Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.
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 due to a regulatory compliance issue (lack of 510(k) clearance) rather than a direct safety hazard, fitting the 'Moderate' criteria for voluntary precautionary or minor regulatory recalls.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is voluntarily recalling 372 units of the Genesys Analytical Column, REF 01-05-0017. The product is intended for use with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography for in vitro diagnostic use only. The recall was initiated on November 1, 2018, and was classified as Class II by the FDA.
The reason for the recall is the lack of FDA 510(k) clearance for the device. The affected units were distributed to facilities in Illinois, West Virginia, New Jersey, Arizona, Maryland, and Utah. All serial numbers are included in this recall.
The recall was initiated by the firm and was terminated on June 21, 2022. The FDA classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Affected units
- 372
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 (1)
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 5 recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) 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.
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