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mem42 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
I think recalls also happen after a while due to unforeseen complications. A company must always try to maintain QC as is best, perhaps by innovating systems that check the product in a more effective and correct way, but things could go wrong sometimes. If an equipment fails after shown to be effective causing the product to be defective, the company must investigate every single step and maybe is not as simple to find therefore they may choose to recall the product until the situation is resolved. The FDA must oversee the company’s strategy and assess in every way the adequacy of the recall as well as having to classify it as class I, II or III