Z-2088-2019Class I

Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS...

Name: Z-2088-2019 Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS...
Creator: Qiagen Sciences LLC
Published: 2019-06-05
License: https://open.fda.gov/license/

Qiagen / initiated 2019-06-05 / Terminated / root cause: manufacturing process

FDA source

Qiagen Sciences LLC began a recall of 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... on 2019-06-05. FDA classified it as Class I and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2088-2019
Classification: Class I
Status: Terminated
Initiated: 2019-06-05
Posted: 2019-08-01
Terminated: 2020-08-28
Recalling firm: Qiagen
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
Product code: JJH Clinical Sample Concentrator
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)
Root cause tag: manufacturing process
FDA 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 [email protected]. Questions or concerns, contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: [email protected]
Quantity in commerce: 1240 Kits
Distribution: US Nationwide distribution
Product codes and lots: Lot Numbers: 0605020019 and 0605020020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2088-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-07	2019-08-01

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)