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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device single (specified) analyte controls (assayed and unassayed)
Product CodeJJX
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2019 82 82
2020 77 77
2021 43 43
2022 24 24
2023 22 22
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 225 225
High Test Results 14 14
Missing Information 6 6
Appropriate Term/Code Not Available 5 5
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 4 4
False Positive Result 2 2
Defective Device 1 1
Product Quality Problem 1 1
Sharp Edges 1 1
False Negative Result 1 1
Insufficient Information 1 1
Ambient Temperature Problem 1 1
Device Markings/Labelling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Premature Discharge of Battery 1 1
Use of Device Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 120 120
No Clinical Signs, Symptoms or Conditions 116 116
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Insufficient Information 3 3
Tissue Damage 2 2
Injury 2 2
Erythema 2 2
Exposure to Body Fluids 2 2
Hypoglycemia 2 2
Dry Eye(s) 1 1
Neuropathy 1 1
Hyperglycemia 1 1
Unspecified Infection 1 1
Swelling/ Edema 1 1
Rupture 1 1
Red Eye(s) 1 1
Laceration(s) 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories III Jul-25-2019
3 Abbott Laboratories III May-16-2019
4 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
5 Medline Industries Inc III Feb-19-2021
6 Ortho-Clinical Diagnostics, Inc. III Jun-04-2024
7 Ortho-Clinical Diagnostics, Inc. III Jul-21-2023
8 Ortho-Clinical Diagnostics, Inc. III Nov-17-2021
9 Randox Laboratories Ltd. II Mar-15-2019
10 Sentinel CH SpA III Jul-06-2021
11 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
12 Tosoh Bioscience Inc II Sep-14-2020
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