Overview of recall records associated with Accriva Diagnostics, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5, Class III: 1.
Assayed Whole blood control contains labeling with incorrect performance range.
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Due to an device without a premarket clearance being incorrectly package and distributed.
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy,…
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual…
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was…
This page summarizes recall records in which the official source identifies Accriva Diagnostics, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
