Recall Z-2088-2019— Qiagen Sciences LLC
Class I · Terminated
Class I FDA medical device recall by Qiagen Sciences LLC, initiated 2019-06-05, terminated 2020-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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: 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).
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-06-05
- Terminated
- 2020-08-28
- Firm location
- Germantown, MD, United States
Product description
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.