The Recall Desk

FDA (Devices) recall action 77340

Fisher Diagnostics recalled 2 products on 2017-08-02

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
2017-08-02
Critical
0
Units
358

Why these products were recalled

An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.

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)··2017-08-02

    Fisher Diagnostics Recalls FDP Assay Kits Due to False Negative Risk

    Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.

    Product
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-08-02

    Fisher Diagnostics Recalls FDP Latex Reagent Due to Reduced Sensitivity

    Fisher Diagnostics is recalling specific lots of Pacific Hemostasis FDP Latex Reagent because reduced sensitivity may cause false negative test results.

    Product
    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
    Category
    Distribution
    1 state