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Terminated

QIAamp DSP Virus Kit Cat. No. 60704

FDA Recall Z-0274-2018 · Posted None

Recalling FirmQiagen, GmbH
Recall StatusTerminated
Product CodeN/A
Date Initiated2017-07-22
Date Terminated2018-07-26
Product Quantity555

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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