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Recall Observatory FDA recall evidence

Device 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

Z-2088-2019

June 05, 2019

Class I

Product summary

Firm
Qiagen Sciences LLC
Event
Event 83199
Status
Terminated
Classification
Class I
Quantity
1240 Kits
Official record key
device-enforcement:Z-2088-2019

Official wording

Reason: 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)

Code information: Lot Numbers: 0605020019 and 0605020020

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)