Clark Laboratories Recalls ultra2 Genesys Variants Analyzer for Lack of 510(k)
Clark Laboratories is recalling 14 ultra2 Genesys Variants Analyzer devices because they lack FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
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 due to a regulatory compliance issue (lack of 510(k) clearance) rather than a direct safety hazard like injury or death. This aligns with the rubric for moderate severity involving voluntary precautionary or compliance-driven recalls without reported adverse health consequences.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is voluntarily recalling 14 units of the ultra2 Genesys Variants Analyzer, REF 03-01-0045. The recall was initiated because the devices lack FDA 510(k) clearance. The devices are intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography for in vitro diagnostic use only.
The recall covers all serial numbers of the affected product. The devices were distributed to locations in Illinois, West Virginia, New Jersey, Arizona, Maryland, and Utah. The recall was initiated on November 1, 2018, and was terminated on June 21, 2022.
The FDA classified this recall as Class II. Users should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Affected units
- 14
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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