Sterrad low temperature sterilizer and 2 other sterilizers were used - initially, it was thought that the actual sterilizers were not functioning properly.When run in the sterrad low temperature sterilizer (we tested in 2 different machines), we had the biologicals come back positive.Tested and ran different batches of bi's and it came out fine.We tested the old and new lot # of bi's and it was consistent, there is something wrong with this lot#.Pulled lot from use and put new lot in machine.Eliminated autoclave, so then it must be biologic or incubator.3m rep said it is a user error and that we either didn't get the medium cracked well enough or things were too tightly packed.This is not the case based on the amount of items listed on the sterilization record.I did perform a recall on all items sterilized on the loads with the positive bis as a precaution.We re-educated staff.We put the sterilizer back into service and the bundle failed.The deduction then is that the biologic is what is defective.
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