FDA-Device2019-08-07Class I

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

Qiagen Sciences LLC
Hazard

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)

Sold states
US Nationwide distribution
Affected count
1240 Kits
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2019

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