The Recall Desk

FDA (Devices) recall action 71291

Remel Inc recalled 2 products on 2015-07-01

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
2015-07-01
Critical
0
Units
164

Why these products were recalled

Use of the recalled product may result in false positive reports.

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)··2015-07-01

    Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports

    Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.

    Product
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2015-07-01

    Remel VersaTREK Instrument Series 528 Recalled for False Positive Reports

    Remel Inc. is recalling 21 VersaTREK Instrument Series 528 devices because their use may result in false positive reports.

    Product
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Distribution
    14 states