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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phosphomolybdate (colorimetric), inorganic phosphorus
Regulation Description Phosphorus (inorganic) test system.
Product CodeCEO
Regulation Number 862.1580
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 3 3
2022 2 2
2023 5 5
2024 5 5
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 12 12
High Test Results 8 8
Non Reproducible Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Measurement 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-08-2025
2 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
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