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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibodies, anti-cyclic citrullinated peptide (ccp)
Definition The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Product CodeNHX
Regulation Number 866.5775
Device Class 2

MDR Year MDR Reports MDR Events
2019 13 13
2020 3 3
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 13 13
High Test Results 10 10
Low Test Results 1 1
False Positive Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Clinical Signs, Symptoms or Conditions 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II Apr-12-2023
2 Roche Diagnostics Operations, Inc. II Aug-23-2019
3 Siemens Healthcare Diagnostics, Inc II Sep-26-2019
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