RegWardenFDA facility compliance records
Company

Accriva Diagnostics, Inc.

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2022: 1 recalls; 2024: 2 recalls; 2025: 2 recalls; 2026: 1 recalls1201620172018201920202021120222023220242202512026
  • Recalls (7)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-04-30
    Assayed Whole blood control contains labeling with incorrect performance range.
  • Class IIOngoing2025-11-05
    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.
  • Class IIIOngoing2025-10-21
    Due to an device without a premarket clearance being incorrectly package and distributed.
  • Class IIOngoing2024-12-02
    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, and then use the percent inhibition formula in the notice to manually calculate the percenta…
  • Class IICompleted2024-09-27
    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 results, which may lead to patient care mismanagement requiring medical intervention.
  • Class IITerminated2022-03-30
    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 distributed and it displays BASE results not displayed by the US-FDA market cleared device. A…
  • Class IITerminated2016-04-22
    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Accriva Diagnostics, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10048042-accriva-diagnostics-inc/

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