ClearanceBrief
Recall Z-2596-2018 ยท JJH Clinical Sample Concentrator

QIAGEN

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

DateMay 28, 2018
StatusTerminated
ReasonUnderfilled reagent well that could lead to incorrect results
Root causeUnder Investigation by firm
ActionOn 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 di
Quantity287 pcs
DistributionDomestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.