Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Genesys 1 Reagent Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) Due to lack of 510K
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Clark Laboratories, Inc. (dba,Trinity Biotech USA) directly.
Affected Products
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.
Quantity: 252 units
Why Was This Recalled?
lack of 510K
Where Was This Sold?
This product was distributed to 6 states: AZ, IL, MD, NJ, UT, WV
About Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA) has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report