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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device general purpose reagent
Regulation Description General purpose reagent.
Definition A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
Product CodePPM
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 31 31
2023 8 8
2024 6 7
2025 230 230
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 214 214
Contamination of Device Ingredient or Reagent 26 26
Contamination 21 21
Low Test Results 12 13
Device Markings/Labelling Problem 10 10
Non Reproducible Results 2 3
Missing Information 2 2
False Positive Result 2 2
Device Fell 1 1
Unable to Obtain Readings 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 290 291
Insufficient Information 3 3
No Patient Involvement 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agilent Technologies, Inc. III Jul-14-2022
2 Beckman Coulter, Inc. II Mar-25-2024
3 Biocare Medical, LLC II Nov-06-2024
4 Copan Italia II Dec-18-2025
5 Cytocell Ltd. III Mar-24-2022
6 Diagnostica Stago, Inc. II Jun-18-2025
7 GET TESTED INTERNATIONAL AB II Dec-01-2025
8 Immuno-Mycologics, Inc II Apr-29-2026
9 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
10 NeuMoDx Molecular Inc II Jul-28-2023
11 Ortho-Clinical Diagnostics, Inc. II Jul-03-2024
12 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
13 bioMerieux, Inc. II Aug-23-2022
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