FDA Medical Device Recalls (openFDA)
Qiagen, GmbH: QIAamp DSP Virus Kit Cat. No. 60704
- Recall number
- Z-0274-2018
- Recalling firm
- Qiagen, GmbH
- Product
- QIAamp DSP Virus Kit Cat. No. 60704
- Status
- Terminated
- Initiated
- 2017-07-22
- Posted
- not on file
- Terminated
- 2018-07-26
- Reason
- Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
- Root cause
- Nonconforming Material/Component
- 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.
- 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
- Lot, serial or model codes
- QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3004013603
- Firm city
- Hilden
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28