FDA recall Z-2088-2019

Qiagen Sciences LLC · Class I · 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

Reason for recall

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)

Distribution

US Nationwide distribution

Key facts

Status
Terminated
Initiation date
2019-06-05
Report date
2019-08-07
Termination date
2020-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Germantown, MD, United States

Primary source

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