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Product testing did not meet expected stability criteria.
100% Appleberry Juice contaminated with cleaning solution, Peracetic Acid.
Defective container - seal not adhering to bottles
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.
Clostridium botulinum (uneviscerated fish)
foreign objects (black plastic planting film) in granulated onion powder
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Product tested positive for Salmonella.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.