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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 211 211
High Test Results 14 14
Missing Information 6 6
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Adverse Event Without Identified Device or Use Problem 4 4
False Positive Result 2 2
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Premature Discharge of Battery 1 1
Display or Visual Feedback Problem 1 1
False Negative Result 1 1
Defective Device 1 1
Ambient Temperature Problem 1 1
Device Markings/Labelling Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
Sharp Edges 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 102 102
No Patient Involvement 14 14
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Injury 2 2
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Erythema 2 2
Hypoglycemia 2 2
Unspecified Infection 1 1
Laceration(s) 1 1
Neuropathy 1 1
Red Eye(s) 1 1
Hyperglycemia 1 1
Dry Eye(s) 1 1
Rupture 1 1
No Code Available 1 1
Swelling/ Edema 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 Jul-21-2023
7 Ortho-Clinical Diagnostics, Inc. III Nov-17-2021
8 Randox Laboratories Ltd. II Mar-15-2019
9 Sentinel CH SpA III Jul-06-2021
10 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
11 Tosoh Bioscience Inc II Sep-14-2020
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