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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
Product CodeKHE
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA SCIENTIFIC DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 1 1
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Product Quality Problem 1 1
Expiration Date Error 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC III Mar-30-2019
2 Enterix, Inc. II Dec-15-2020
3 Helena Laboratories, Corp. II Jul-05-2019
4 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
5 Roche Diagnostics Corporation II Oct-31-2018
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