Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1320-2013·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, and the hazard involves incorrect vials which may affect test accuracy but does not involve reported injuries or high-risk pathogens.

Plain-English summary

QIAGEN Gaithersburg, Inc. is recalling 90 kits of the artus CMV RG PCR ASR (96) (Catalog number 4503225). The recall was initiated because the kits may contain a mixture of incorrect vials among the correct vials. The affected lots are #142345648 and #142357718, both with an expiration date of 06/09/14.

The product 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. The kits were distributed nationwide in the United States, including California, the District of Columbia, Florida, Georgia, Massachusetts, Maryland, Michigan, and Illinois.

Users of these kits should stop using the affected lots and contact QIAGEN Gaithersburg, Inc. for further instructions. This recall is classified as Class II by the FDA.

The recalled product

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…
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 4503225
Lot #142345648
Exp: 06/09/14 & Lot #142357718 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