The Recall Desk

FDA (Devices) recall action 72322

ELITech Clinical Systems SAS recalled 4 products on 2015-11-11

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-11-11
Critical
0
Units
16,425

Why these products were recalled

ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.

ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.

ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.

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.

1–4 of 4

  • ModerateFDA (Devices)··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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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…
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    0 states