Devices

Device Recall Hc2 System Software

Model / Serial
hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
The recalled product was sold to medical laboratories nationwide and in Canada.
Product Description
Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. || The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)
Manufacturer
QIAGEN Gaithersburg, Inc.
1 Event
- Recall of Device Recall Hc2 System Software

Manufacturer

QIAGEN Gaithersburg, Inc.

Manufacturer Address
QIAGEN Gaithersburg, Inc., 1201 Clopper Rd, Gaithersburg MD 20878-4000
Manufacturer Parent Company (2017)
QIAGEN N.V.
Source
USFDA

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