Accumetrics, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
Verifynow-Aspirin Assay Ref K042423
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Verifynow-P2Y12 Assay Ref K051231
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
2014
- 13 Feb 2014 Z-1172-2014 Class II Terminated Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
2013
- 14 Nov 2013 Z-0482-2014 Class II Terminated Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
2012
- 6 Feb 2012 Z-1853-2012 Class II Terminated The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
- 6 Feb 2012 Z-1854-2012 Class II Terminated The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
2006
- 5 Sep 2006 Z-0228-2007 Unclassified (pre-2012) Terminated The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
Full distribution text
- 5 Sep 2006 Z-0228-2007 Unclassified (pre-2012) Terminated The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
2005
- 13 Sep 2005 Z-0102-06 Unclassified (pre-2012) Terminated In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.
2004
- 10 May 2004 Z-1018-04 Unclassified (pre-2012) Terminated Test results too low in control.
Frequently asked questions
How many devices does Accumetrics, Inc. have in the registry?
The registry currently lists 7 devices for Accumetrics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accumetrics, Inc.'s devices?
Among its 7 most recently registered devices, Accumetrics, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Accumetrics, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Accumetrics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Accumetrics, Inc.?
FDA recall records list 7 recalls initiated by Accumetrics, Inc., the most recent initiated on 13 Feb 2014. 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 Accumetrics, Inc. in the registry?
The most recently registered devices listed for Accumetrics, Inc. include ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA), VERIFYNOW-ASPIRIN ASSAY, MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) and ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA).