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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 14 14
High Test Results 11 11
False Positive Result 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Low Test Results 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 10 10

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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