Clark Laboratories, Inc. (dba,Trinity Biotech USA): Medical Device Recall in 2018 - (Recall #: Z-0623-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 1, 2018

Date Posted: December 26, 2018

Recall Number: Z-0623-2019

Event ID: 81488

Reason for Recall:

lack of 510K

Status: Terminated

Product Quantity: 216 units

Code Information:

all serial numbers

Distribution Pattern:

IL, WV, NJ, AZ, MD, UT

Voluntary or Mandated:

Voluntary: Firm initiated