Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance
Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.
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 is driven by a regulatory compliance issue (lack of 510(k)) rather than a specific safety hazard or reported injury, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is voluntarily recalling 216 units of Genesys 2 Reagent, REF 01-03-0022. The product is an in vitro diagnostic reagent intended for use with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography.
The recall was initiated because the product lacks the required FDA 510(k) clearance. The recall was classified as Class II by the FDA. The affected units were distributed 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 firm notified customers via letter. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Affected units
- 216
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.
See all 5 products in this recall →Related recalls
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