Recall Z-0274-2018
Qiagen, GmbH · initiated July 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QIAamp DSP Virus Kit Cat. No. 60704
Codes / lots: QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.
Reason for recall
Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
FDA-determined cause: Nonconforming Material/Component
Action taken
Qiagen 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.
Details
- Recall number
- Z-0274-2018
- Initiated
- July 22, 2017
- Terminated
- July 26, 2018
- Quantity
- 555
- 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
- Recalling firm
- Qiagen, GmbH, Hilden