Manufacturer
3 recalls in our database name Arkray Factory USA, Inc. as the manufacturing or recalling firm.
Of the 3 recalls from Arkray Factory USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Arkray Factory USA, Inc. is recalling 159 AUTION HYBRID AU-4050 units due to a software issue that could assign incorrect patient information to sample results.
Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.
Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.