FDA Device Intelligence
Home › CEPHEID › Xpert Factor II & Factor V

Xpert Factor II & Factor V

CEPHEID · Model GXFIIFV-10 · UDI-DI 07332940000240

NPRNPQ Prescription
2
510(k) clearances
5
Adverse events
2
Recalls
4
Facilities

Description

Xpert Factor II & Factor V kit; 10 test kit

Recalls

DateFirmReason
2010-10-26Roche Diagnostics Operations, Inc.If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the
2009-03-12Roche Molecular Systems, Inc.Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and the

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.