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What Do Consumers and Health Care Providers Need To Do?
CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.
The information above concerning the storage and recording of time/temperature conditions are applicable to other non-blood biologicals requiring refrigeration or frozen storage.
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