The Recall Desk

FDA (Devices) recall action 84043

Axis-Shield Diagnostics, Ltd. recalled 3 products on 2020-01-01

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-01-01
Critical
0
Units
2,220

Why these products were recalled

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

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

1–3 of 3

  • ModerateFDA (Devices)··2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Distribution
    2 states