The Recall Desk

FDA (Devices) recall action 64650

QIAGEN Gaithersburg, Inc. recalled 2 products on 2013-05-22

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
2013-05-22
Critical
0
Units
180

Why these products were recalled

CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

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)··2013-05-22

    QIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture

    QIAGEN is recalling artus CMV RG PCR kits because they may contain incorrect vials mixed with correct ones, potentially affecting test accuracy.

    Product
    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2013-05-22

    QIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture

    QIAGEN is recalling artus CMV RG PCR kits because they may contain incorrect vials mixed with correct ones, potentially affecting test accuracy.

    Product
    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook
    Category
    Distribution
    8 states