FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2088-2019
- Recalling firm
- Qiagen Sciences LLC
- 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
- Status
- Terminated
- Initiated
- 2019-06-05
- Posted
- 2019-08-01
- Terminated
- 2020-08-28
- 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 environmental regulations. l Review this notice with your laboratory/medical director. l If you have used the affected kits with lots 0605020019 and/or 0605020020, we recommend a review of the corresponding results. l Complete the Acknowledgement of Receipt form attached to this letter by June 12, 2019 and email it to quality.communications@qiagen.com. Questions or concerns, contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
- Quantity
- 1240 Kits
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- Lot Numbers: 0605020019 and 0605020020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJH
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28