Qiagen RNeasy DSP FFPE Kit Recalled Due to Contaminant
Qiagen is recalling 31 units of the RNeasy DSP FFPE Kit because a contaminant in the deparaffinization solution reduces RNA purification efficiency.
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. The hazard involves reduced test sensitivity and yield rather than direct physical injury or acute health risk, fitting the criteria for moderate severity.
Plain-English summary
Qiagen Sciences, Inc. is recalling 31 units of the RNeasy DSP FFPE Kit (REF 73604), Lot 163016105. The product is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues for in vitro diagnostic use by professional users.
The recall was initiated because the deparaffinization solution contains a contaminant. This contaminant leads to reduced lysis efficiency, resulting in significantly reduced yields and less sensitive downstream applications.
The affected products were distributed in the United States to Massachusetts, Rhode Island, Arizona, New York, North Carolina, Indiana, and Texas. They were also distributed to Germany, Great Britain, Italy, France, Sweden, and Switzerland. Users should stop using the affected lot and contact the manufacturer for instructions.
The recalled product
- Product
- RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians…
- Manufacturer
- Qiagen Sciences, Inc.
- Affected units
- 31
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 (1)
- LOT 163016105
Distribution
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