Recall Z-1320-2013— QIAGEN Gaithersburg, Inc.
Class II · Terminated
Class II FDA medical device recall by QIAGEN Gaithersburg, Inc., initiated 2013-01-30, terminated 2013-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- QIAGEN Gaithersburg, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-30
- Terminated
- 2013-07-01
- Firm location
- Gaithersburg, MD, United States
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.
Reason for recall
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Data sourced from openFDA. This site is unofficial and independent of the FDA.