Diadexus, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Diadexus Plac Test Ref K030477
Regimes: 510(k) Registry: 510(k)Modification To Diadexus Plac Test Ref K040101
Regimes: 510(k) Registry: 510(k)Plac Test For LP-PLA2 Activity Ref K141575
Regimes: 510(k) Registry: 510(k)Diadexus Plac Test Ref K050523
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Plac Test Reagent Kit, Calibrator Kit, LP-PLA2 Control Kit, Model(S) 90107, 90109, 90109 Ref K072599
Regimes: 510(k) Registry: 510(k)Modification To Diadexus Plac Test Ref K062234
Regimes: 510(k) Registry: 510(k)
FDA recalls
2010
- 20 Aug 2010 Z-1737-2011 Unclassified (pre-2012) Terminated Product fails stability tests prior to expiration date.
Full distribution text
- 15 Mar 2010 Z-0429-2011 Unclassified (pre-2012) Terminated The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml. Results up to 500 ng/ml exhibit passing stability results and are not impacted by this issue.
- 20 Aug 2010 Z-1737-2011 Unclassified (pre-2012) Terminated Product fails stability tests prior to expiration date.
2009
- 29 Oct 2009 Z-1748-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 29 Oct 2009 Z-1749-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 29 Oct 2009 Z-1750-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 29 Oct 2009 Z-1751-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 29 Oct 2009 Z-1752-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 29 Oct 2009 Z-1753-2010 Unclassified (pre-2012) Terminated Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
- 9 Feb 2009 Z-1205-2009 Unclassified (pre-2012) Terminated Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
2008
- 4 Nov 2008 Z-1204-2009 Unclassified (pre-2012) Terminated Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
Show all 12 recalls
2008
- 18 Jul 2008 Z-2399-2008 Unclassified (pre-2012) Terminated Product may give Lp-PLA2 values at up to 22% lower than accurate values.
- 18 Jul 2008 Z-2400-2008 Unclassified (pre-2012) Terminated Product may give Lp-PLA2 values at up to 22% lower than accurate values.
Frequently asked questions
How many devices does Diadexus, Inc. have in the registry?
The registry currently lists 7 devices for Diadexus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diadexus, Inc.'s devices?
Among its 7 most recently registered devices, Diadexus, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Diadexus, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Diadexus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Diadexus, Inc.?
FDA recall records list 12 recalls initiated by Diadexus, Inc., the most recent initiated on 2010-08-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Diadexus, Inc. in the registry?
The most recently registered devices listed for Diadexus, Inc. include DIADEXUS PLAC TEST, MODIFICATION TO DIADEXUS PLAC TEST, PLAC TEST FOR LP-PLA2 ACTIVITY and PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115.