Qiagen QIAamp DSP Virus Kit Recalled for Decreased Performance
Qiagen is recalling specific lots of the QIAamp DSP Virus Kit because they may result in decreased performance in analytic workflows.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The source text notes decreased performance without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Qiagen, GmbH is recalling 555 units of the QIAamp DSP Virus Kit, Catalog No. 60704. The recall affects specific lots: 154025928, 154027751, 154029053, 154029743, and 154029744.
The recall was initiated because certain lots of the kit used in analytic workflows could result in decreased performance. The agency has classified this as a Class II recall.
The affected products were distributed in the United States and numerous international locations, including Argentina, Austria, Belgium, China, Germany, France, and the United Kingdom. Users should check their inventory for the specific lot numbers listed above and stop using the affected kits.
The recalled product
- Product
- QIAamp DSP Virus Kit Cat. No. 60704
- Manufacturer
- Qiagen, GmbH
- Hazard
- Affected units
- 555
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 (6)
- QIAamp DSP Virus Kit
- Cat. No. 60704
- lot 154025928
- 154027751
- 154029053
- 154029743 and 154029744.
Distribution
Distribution scope not specified by the agency.
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