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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

QIAGEN Gaithersburg, Inc.: CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

Agency Publication Date: May 14, 2013
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Affected Products

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.

Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14

Lot Numbers:
142345648
142357718
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).

Catalog Number 4503223, Lot #142345647, Exp: 06/09/14

Lot Numbers:
142345647

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64650
Status: Resolved
Manufacturer: QIAGEN Gaithersburg, Inc.
Manufactured In: United States
Units Affected: 2 products (90 kits in total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.