Recall Z-1320-2013 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
QIAGEN Gaithersburg, Inc.
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.
| Date | May 14, 2013 (initiated Jan 30, 2013) |
| Status | Terminated |
| Reason | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. |
| 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 |
| Quantity | 90 kits in total |
| Distribution | USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.