The Recall Desk

FDA (Devices) recall action 74505

Alere San Diego, Inc. recalled 7 products on 2016-08-03

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2016-08-03
Critical
0
Units
—

Why these products were recalled

The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

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

1–7 of 7

  • LowFDA (Devices)··2016-08-03

    Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error

    Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere Mono Rapid Test Recalled for Incorrect Labeling Information

    Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere Proadvantage Mono Rapid Test Cassette Recalled for Labeling Error

    Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere San Diego Recalls Stanbio Rely Mono Rapid Test for Labeling Error

    Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere Signify Mono Test Recalled for Incorrect Labeling Information

    Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere Clearview MONO Test Recalled for Incorrect Labeling

    Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2016-08-03

    Alere Acceava Mono II Rapid Test Strip Labeling Recall

    Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
    Category
    Distribution
    0 states