EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Recall
- Recall Number
- Z-2596-2018
- Event Number
- 80430
- Firm
- QIAGEN 19300 GERMANTOWN RD GERMANTOWN MD 20874 USA KOELN Germany
- FEI Number
- 3013155221
- Product Code
- JJH
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 28, 2018
- Terminated
- April 5, 2019
Description
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Underfilled reagent well that could lead to incorrect results
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].
Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
287 pcs