QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect

FDA device recall Z-1321-2013 · posted 2013-05-14 · Terminated

Recall details

Recalling firm

QIAGEN Gaithersburg, Inc.

Reason for recall

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

Action taken

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, techservice-na@qiagen.com. 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 techservice-na@qiagen.com.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

LKQ

Quantity affected

90 kits in total

Distribution

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

Date initiated

2013-01-30

Date posted

2013-05-14

Date terminated

2013-07-01

Location

Gaithersburg, MD