Medical device recalls High risk

Qiagen Sciences LLC recalls Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instrument…

Recall date
June 5, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2088-2019
FDA classification
Class I
Brand / firm
Qiagen Sciences LLC
Sold / distributed
US Nationwide distribution

Why it was recalled

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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