The Recall Desk

FDA (Devices) recall action 81488

Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalled 5 products on 2018-12-26

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-12-26
Critical
0
Units
1,317

Why these products were recalled

lack of 510K

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2018-12-26

    Clark Laboratories Recalls Genesys Diluent Reagent for Lack of 510(k) Clearance

    Clark Laboratories is recalling 463 units of Genesys Diluent Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.

    Product
    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.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-12-26

    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.

    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.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-12-26

    Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance

    Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.

    Product
    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.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-12-26

    Clark Laboratories Recalls ultra2 Genesys Variants Analyzer for Lack of 510(k)

    Clark Laboratories is recalling 14 ultra2 Genesys Variants Analyzer devices because they lack FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.

    Product
    ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-12-26

    Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance

    Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.

    Product
    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.
    Category
    Distribution
    6 states