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

Recall number

Z-2596-2018

Recalling firm

QIAGEN

Product

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

Status

Terminated

Initiated

2018-05-28

Posted

not on file

Terminated

2019-04-05

Reason

Underfilled reagent well that could lead to incorrect results

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: quality.communications@qiagen.com.

Quantity

287 pcs

Distribution

Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA

Lot, serial or model codes

UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJH

Firm FEI

3013155221

Firm city

KOELN

Firm state

MD

Firm country

Germany

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

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