ClearanceBrief
Recall Z-0274-2018 ยท N/A

Qiagen, GmbH

QIAamp DSP Virus Kit Cat. No. 60704

DateJul 22, 2017
StatusTerminated
ReasonCertain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
Root causeNonconforming Material/Component
ActionQiagen sent ffected customers and commercial partners "Urgent Notice of Product Field Action", dated June 22, 2017 via an e-mail containing a letter as pdf. In the letter, customers were informed of the reason for recall, with an overview of affected products, detailed description of issue, consequences of the issue, actions to be taken by the customer/user, completion of the acknowledgement of receipt form, contact information and the commercial partners are instructed to forward , actions that have been initiated by AIAGEN, the letter to their customers.
Quantity555
DistributionAR; AT; BE; CH; CN; CZ; DE; ES; FR; GB; GR; HK; IN; IR, IT; KR; MX; NL; NP, PH; PK; PL; TR, TW; US; UY, VN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.