Home / Recalls / Clark Laboratories, Inc. (dba,Trinity Biotech USA) / Z-0624-2019

Z-0624-2019 Class II Terminated

Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) — Jamestown, NY

Recall Details

Product Type
Devices
Report Date
December 26, 2018
Initiation Date
November 1, 2018
Termination Date
June 21, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
463 units

Product Description

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.

Reason for Recall

lack of 510K

Distribution Pattern

IL, WV, NJ, AZ, MD, UT

Code Information

all serial numbers

Other recalls by Clark Laboratories, Inc. (dba,Trinity Biotech USA)

  • Z-0621-2019 Class II — Genesys Analytical Column, REF 01-05-0017 intended to be used with automated hig (November 1, 2018)
  • Z-0623-2019 Class II — Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high perfor (November 1, 2018)
  • Z-0622-2019 Class II — Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high perfor (November 1, 2018)
  • Z-0620-2019 Class II — ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automa (November 1, 2018)
  • Z-2782-2016 Class III — Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Det (July 11, 2016)
  • Z-0819-2015 Class III — Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-9 (November 17, 2014)
  • Z-0572-2014 Class II — Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for (August 27, 2013)
  • Z-2445-2012 Class III — Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2 (May 29, 2012)