Clark Laboratories Recalls Genesys 1 Reagent for Lack of 510(k) Clearance
Clark Laboratories is recalling 252 units of Genesys 1 Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and has been terminated.
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, fitting the criteria for moderate severity involving minor labeling or documentation issues.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is voluntarily recalling 252 units of Genesys 1 Reagent, REF 01-03-0020. This 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 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 firm notified customers via letter.
The recall status is currently Terminated, with a termination date of June 21, 2022. Users of this product should contact the manufacturer or their supplier for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
- Affected units
- 252
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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