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.
FDA Recall Z-1320-2013 · Posted 2013-05-14
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Recalling FirmQIAGEN Gaithersburg, Inc.
Recall StatusTerminated
Product CodeLKQ
Date Initiated2013-01-30
Date Terminated2013-07-01
Product Quantity90 kits in total
Reason for Recall
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Firm 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].
Root Cause
Mixed-up of materials/components
Distribution Pattern
USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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