Recall Z-2088-2019 ยท JJH Clinical Sample Concentrator
Qiagen Sciences LLC
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
| Date | Aug 1, 2019 (initiated Jun 5, 2019) |
| Status | Terminated |
| 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) |
| Root cause | Process control |
| Action | QIAGEN issued Urgent Device Notification dated June 5, 2019 stating problem, health risk and action to take: Forward this information to all individuals and departments who are using the above listed kit within your organization. If you are not the end user, please forward this notice to the product end user. If you have any remaining stocks of Filter-Tips, 1500 l (1024) REF 997024, lots 0605020019 and 0605020020, DO NOT USE them. For a free-of-charge replacement, please contact QIAGEN Technical Service. Dispose of the product in accordance with your national and local safety and environment |
| Quantity | 1240 Kits |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.