Z-0274-2018Class II

QIAamp DSP Virus Kit Cat. No. 60704

Name: Z-0274-2018 QIAamp DSP Virus Kit Cat. No. 60704
Creator: Qiagen, GmbH
Published: 2017-07-22
License: https://open.fda.gov/license/

Qiagen / initiated 2017-07-22 / Terminated / root cause: manufacturing process

FDA source

Qiagen, GmbH began a recall of QIAamp DSP Virus Kit Cat. No. 60704 on 2017-07-22. FDA classified it as Class II and gives the reason as "Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0274-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-22
Posted: 2017-12-21
Terminated: 2018-07-26
Recalling firm: Qiagen
Product: QIAamp DSP Virus Kit Cat. No. 60704
Product code: N/A
Reason for recall: Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0274-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0274-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)