The Recall Desk

FDA (Devices) recall action 63918

Alere San Diego, Inc. recalled 2 products on 2013-02-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-02-06
Critical
0
Units
11,780

Why these products were recalled

Out of range (increased) HDL Cholesterol results.

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

1–2 of 2

  • LowFDA (Devices)··2013-02-06

    Alere Cholestech LDX Calibration Verification Recall for HDL Errors

    Alere San Diego, Inc. is recalling 614 kits of Cholestech LDX Calibration Verification due to out-of-range HDL cholesterol results.

    Product
    Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL)…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2013-02-06

    Alere Cholestech LDX Multianalyte Control Recalled for HDL Errors

    Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control kits because they may produce out-of-range HDL cholesterol results.

    Product
    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL)…
    Category
    Distribution
    1 state