Clark Laboratories Recalls Genesys Diluent Reagent for Lack of 510(k) Clearance
Clark Laboratories is recalling 463 units of Genesys Diluent Reagent because the product lacks 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 and is due to a regulatory documentation issue (lack of 510(k) clearance) rather than a direct 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 463 units of Genesys Diluent Reagent, REF 01-03-0019. The product is intended for use with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography and is for in vitro diagnostic use only.
The recall was initiated because the product lacks FDA 510(k) clearance. The recall was initiated on November 1, 2018, and was classified as Class II by the FDA. The affected units were distributed to facilities in Illinois, West Virginia, New Jersey, Arizona, Maryland, and Utah.
The recall status is currently Terminated. Users should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Affected units
- 463
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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