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.
What this means for you
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 handbook
- Manufacturer
- QIAGEN Gaithersburg, Inc.
- 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
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 →Related recalls
Same manufacturer · QIAGEN Gaithersburg, Inc.
See all →- ModerateQIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture
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