FDA Recall Terminated

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.

Recall: Z-1320-2013 · Initiated January 30, 2013

Recall

Recall Number
Z-1320-2013
Event Number
64650
Firm
QIAGEN Gaithersburg, Inc.
FEI Number
3003572099
Product Code
LKQ
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
January 30, 2013
Posted
May 14, 2013
Terminated
July 1, 2013
Address
1201 Clopper Rd, Gaithersburg, MD, 20878-4000

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.

Reason

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

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].

Distribution

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

Quantity

90 kits in total