The Recall Desk

Manufacturer

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

9 recalls in our database name Clark Laboratories, Inc. (dba,Trinity Biotech USA) as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2018-12-26

Of the 9 recalls from Clark Laboratories, Inc. (dba,Trinity Biotech USA) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • ModerateFDA (Devices)·Z-0621-2019·2018-12-26

    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
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0624-2019·2018-12-26

    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
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0622-2019·2018-12-26

    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
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0623-2019·2018-12-26

    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
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0620-2019·2018-12-26

    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
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2782-2016·2016-09-21

    Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure

    Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.

    Product
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0819-2015·2014-12-24

    Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure

    Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.

    Product
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0572-2014·2014-01-01

    Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives

    Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.

    Product
    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2445-2012·2012-10-03

    Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues

    Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.

    Product
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
    Category
    Medical Device
    Distribution
    Distributed nationwide