Z-2596-2018Class II

EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use

Name: Z-2596-2018 EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use
Creator: Qiagen
Published: 2018-05-28
License: https://open.fda.gov/license/

Qiagen / initiated 2018-05-28 / Terminated

FDA source

QIAGEN began a recall of EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use on 2018-05-28. FDA classified it as Class II and gives the reason as "Underfilled reagent well that could lead to incorrect results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2596-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-28
Posted: 2018-08-02
Terminated: 2019-04-05
Recalling firm: Qiagen
Product: EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Product code: JJH Clinical Sample Concentrator
Reason for recall: Underfilled reagent well that could lead to incorrect results
FDA root cause: Under Investigation by firm
Action: On May 28, 2018 QIAGEN issued an Urgent Notice of Product Field Action and a Acknowledgement of Receipt form to customers. Actions to be taken by the customer/user/commercial partner are as follows: - If you have any remaining stocks, do not use them, contact our technical service for a free-of-charge replacement and dispose of the product in accordance with your national, local safety and environmental regulations. - Review the notice with your laboratory/medical director. - Forward the information to all individuals and departments within your organization. - If product was further distributed, forward a copy of the notice to the product end user. - QIAGEN also recommends a review of the corresponding results. Consider the possibility of under-quantification and false negative results and evaluate the need for retesting with different EZ1 DSP Virus Kit lots e.g. depending on the clinical presentation and history of the patient - Complete and return the Acknowledgement of Receipt form and email to: [email protected].
Quantity in commerce: 287 pcs
Distribution: Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Product codes and lots: UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2596-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2596-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)