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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)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJX
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2020 77 77
2021 43 43
2022 24 24
2023 22 22
2024 30 30
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 170 170
Missing Information 5 5
Appropriate Term/Code Not Available 4 4
Improper or Incorrect Procedure or Method 4 4
Adverse Event Without Identified Device or Use Problem 3 3
False Negative Result 2 2
False Positive Result 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
Use of Device Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Ambient Temperature Problem 1 1
Premature Discharge of Battery 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
No Known Impact Or Consequence To Patient 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Insufficient Information 3 3
Erythema 2 2
Hypoglycemia 2 2
Unspecified Infection 1 1
Neuropathy 1 1
Red Eye(s) 1 1
No Code Available 1 1
Dry Eye(s) 1 1
Rupture 1 1
Burn(s) 1 1
Hyperglycemia 1 1
Laceration(s) 1 1
Swelling/ Edema 1 1

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