Recall Z-2596-2018
Qiagen · initiated May 28, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Codes / lots: UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19
Reason for recall
Underfilled reagent well that could lead to incorrect results
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2596-2018
- Initiated
- May 28, 2018
- Terminated
- April 5, 2019
- Product code
- JJH – Clinical Sample Concentrator
- Quantity
- 287 pcs
- Distribution
- Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
- Recalling firm
- Qiagen, Koeln, MD