The Recall Desk

Manufacturer

ELITech Clinical Systems SAS

6 recalls in our database name ELITech Clinical Systems SAS as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2018-08-08

Of the 6 recalls from ELITech Clinical Systems SAS 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.

1–6 of 6

  • ModerateFDA (Devices)·Z-2591-2018·2018-08-08

    ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures

    ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.

    Product
    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0217-2016·2015-11-11

    ELITech Envoy 500 Reagent Kits Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.

    Product
    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2016·2015-11-11

    ELITech Eon 100 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2016·2015-11-11

    ELITech Clinical Systems reagents recalled for potential drug interference

    ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.

    Product
    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2016·2015-11-11

    ELITech Eon 300 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2015·2014-10-08

    Recall of ENVOY 500 AST Reagent Kits Due to Quality Control Failures

    ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.

    Product
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide