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Possible contamination with Listeria monocytogenes
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
High histamine levels in Yellowfin Tuna
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Sterilization certificates could not be validated by the supplier
Undeclared Wheat Allergen
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.