Accumetrics recalls
Accumetrics appears in 4 official U.S. recall notices indexed by RecallRadar, most recently on 2014-03-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 4 |
|---|---|
| Published | 2012-06-27 to 2014-03-19 |
| By agency | FDA Device (4) |
| By classification | Class II (4) |
| By status | terminated (4) |
| Distribution named in notices | US |
Recalls
- VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit
FDA Device · Class II · 2014-03-19 · Accumetrics
Reason: 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 calc… - VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box
FDA Device · Class II · 2013-12-18 · Accumetrics
Reason: 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 i… - VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots
FDA Device · Class II · 2012-06-27 · Accumetrics
Reason: 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 va… - VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of…
FDA Device · Class II · 2012-06-27 · Accumetrics
Reason: 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 va…