The Recall Desk

FDA (Devices) recall action 83088

Helena Laboratories, Corp. recalled 2 products on 2019-07-17

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
2019-07-17
Critical
0
Units
—

Why these products were recalled

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.

    Product
    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Distribution
    34 states
  • ModerateFDA (Devices)··2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Distribution
    34 states