The Recall Desk

FDA (Devices) recall action 67245

Becton Dickinson & Co. recalled 2 products on 2014-02-05

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
2014-02-05
Critical
0
Units
200

Why these products were recalled

Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

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

  • HighFDA (Devices)··2014-02-05

    BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.

    Product
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapi
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-05

    BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.

    Product
    BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly i
    Category
    Distribution
    1 state