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Lack of Assurance of Sterility
CGMP Deviations: Potential presence of metal particulate matter
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Half-pint chocolate fat free milk is recalled due to potential quality control issues.