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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibody igm,if, cytomegalovirus virus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLKQ
Regulation Number 866.3175
Device Class 2

MDR Year MDR Reports MDR Events
2021 68 68
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Calibrate 78 78
False Negative Result 5 5
Low Test Results 2 2
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Apr-10-2021
2 bioMerieux, Inc. II Mar-14-2022
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