Qiagen Filter-Tips Recalled for Leaking During Sample Preparation
Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Qiagen Sciences LLC is recalling 1,240 kits of Filter-Tips, 1500 ul (REF 997024), distributed nationwide in the United States. The affected lots are 0605020019 and 0605020020. These tips are used in sample preparation with QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301).
The recall was initiated because kit lots contain a small percentage of damaged Filter-Tips that leak when used with the specified instruments. This defect may compromise the integrity of the sample preparation process.
Users of these products should stop using the affected lots immediately. The recall is classified as FDA Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death, although the source text does not explicitly report specific injuries or illnesses.
The recalled product
- Product
- Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- Affected units
- 1,240
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 Numbers: 0605020019 and 0605020020
Distribution
Distributed nationwide across the United States.
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