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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, occult blood
Regulation Description Occult blood test.
Product CodeKHE
Regulation Number 864.6550
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2023 1 1
2024 1 1
2025 3 3
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Non Reproducible Results 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Labelling, Instructions for Use or Training Problem 1 1
False Positive Result 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Enterix, Inc. II Nov-28-2025
2 GET TESTED INTERNATIONAL AB II Dec-01-2025
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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