Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Genesys Analytical Column 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 Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Quantity: 372 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.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report