QIAGEN Gaithersburg, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1320-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

Product Classification:

Class II

Date Initiated: January 30, 2013

Date Posted: May 22, 2013

Recall Number: Z-1320-2013

Event ID: 64650

Reason for Recall:

CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

Status: Terminated

Product Quantity: 90 kits in total

Code Information:

Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14

Distribution Pattern:

USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated