EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in… recallZ-2596-2018 · Qiagen · initiated May 28, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Qiagen or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Underfilled reagent well that could lead to incorrect results
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-2596-2018
- Status
- Terminated
- Initiated by the company
- May 28, 2018
- Recalling firm
- Qiagen
- Quantity
- 287 pcs
- Product code
- JJH
- Distribution
- Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Product description
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Code information (models, lots, serial numbers)
UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EZ1 DSP Virus Kit 4QIAGEN GmbH · Clinical Sample Concentrator1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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