FDA Enforcement Class II Terminated

QIAamp DSP Virus Kit Cat. No. 60704

Recall: Z-0274-2018 · Reported December 27, 2017

Enforcement

Recall Number
Z-0274-2018
Event ID
78646
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Qiagen, GmbH
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
December 27, 2017
Initiation Date
July 22, 2017
Classification Date
December 21, 2017
Termination Date
July 26, 2018
Address
Qiagen Str. 1, Hilden, N/A, Germany

Description

QIAamp DSP Virus Kit Cat. No. 60704

Reason

Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.

Code Info

QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.

Distribution

AR; 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

Quantity

555