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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detergent
Product CodeJCB
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bacterial Infection 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-20-2014
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