The Recall Desk

FDA (Devices) recall action 83053

Abbott Laboratories recalled 2 products on 2019-07-31

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
2019-07-31
Critical
0
Units
12,106

Why these products were recalled

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP 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

1–2 of 2

  • ModerateFDA (Devices)··2019-07-31

    Abbott Recalls ARCHITECT BNP Calibrators Due to Stability Drift

    Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.

    Product
    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
    Category
    Distribution
    48 states
  • LowFDA (Devices)··2019-07-31

    Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift

    Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.

    Product
    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of h
    Category
    Distribution
    48 states