Z-1321-2013Class II

QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)

Name: Z-1321-2013 QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)
Creator: QIAGEN Gaithersburg, Inc.
Published: 2013-01-30
License: https://open.fda.gov/license/

Qiagen / initiated 2013-01-30 / Terminated

FDA source

QIAGEN Gaithersburg, Inc. began a recall of QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific... on 2013-01-30. FDA classified it as Class II and gives the reason as "CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1321-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-30
Posted: 2013-05-14
Terminated: 2013-07-01
Recalling firm: Qiagen
Product: QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
Product code: LKQ Antibody Igm,If, Cytomegalovirus Virus
Reason for recall: CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
FDA root cause: Mixed-up of materials/components
Action: Qiagen Gaithersburg, Inc. issued a PRODUCT FIELD ACTION letter dated February 4, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the vials prior to use to ensure that the vials are labeled "CMV RG Master" Vials labeled "EBV TM Master" should NOT be used and count the vials and discard per internal laboratory procedures. Qiagen will replace free of charge or credit any kits discovered with incorrect master mix vials. Please complete page 2 of this notice as soon as possible and email or fax it back to us at: (661) 702-3854, [email protected]. If you have additional questions or concerns polease do not hestiate to call QIAGEN Technical Services at 1-800-344-3631 option 2 or by e-mail [email protected].
Quantity in commerce: 90 kits in total
Distribution: USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
Product codes and lots: Catalog Number 4503223, Lot #142345647, Exp: 06/09/14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1320-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14
Z-1321-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14

Product code LKQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)