The Recall Desk

Manufacturer

QIAGEN Gaithersburg, Inc.

2 recalls in our database name QIAGEN Gaithersburg, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2013-05-22

Of the 2 recalls from QIAGEN Gaithersburg, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-1321-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide