Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1321-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the product could cause temporary or medically reversible adverse health consequences, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

QIAGEN Gaithersburg, Inc. is recalling 90 kits of the artus CMV RG PCR ASR (Catalog number 4503223). The recall is due to a potential mixture of incorrect vials among the correct vials in the kits. These kits are designed to detect and quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology.

The affected products are identified by Lot #142345647 with an expiration date of 06/09/14. The kits were distributed nationwide in the United States, including the states of California, District of Columbia, Florida, Georgia, Massachusetts, Maryland, Michigan, and Illinois.

Users of these kits should stop using them immediately and contact QIAGEN Gaithersburg, Inc. for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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).
Manufacturer: QIAGEN Gaithersburg, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
incorrect-component
Affected units: 90

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by QIAGEN Gaithersburg, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · QIAGEN Gaithersburg, Inc.

See all →

Moderate
QIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture
FDA (Devices) · 2013-05-22

Same hazard · mis labeling