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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


Premarket Reviews
ManufacturerDecision
AALTO SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 7
AALTO SCIENTIFIC, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN BIOLOGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
APEX BIO TECHNOLOGY CORP
  SUBSTANTIALLY EQUIVALENT 1
BAYER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
CLINIQA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CONE BIOPRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 4
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 6
MAINE STANDARDS CO.
  SUBSTANTIALLY EQUIVALENT 2
MAINE STANDARDS COMPANY LLC
  SUBSTANTIALLY EQUIVALENT 1
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTIMETRIX CORP.
  SUBSTANTIALLY EQUIVALENT 2
QUANTIMETRIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES, LTD.
  SUBSTANTIALLY EQUIVALENT 4
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 33
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
ROCHE DIAGNOSTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 16
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS HELATHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TECHNOPATH MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 48 48
2015 67 67
2016 37 37
2017 19 19
2018 35 35
2019 82 82
2020 77 77
2021 43 43
2022 24 24
2023 22 22
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 288 288
Device Operates Differently Than Expected 56 56
High Test Results 37 37
Display or Visual Feedback Problem 36 36
Incorrect Or Inadequate Test Results 27 27
Improper or Incorrect Procedure or Method 14 14
Nonstandard Device 8 8
Use of Incorrect Control/Treatment Settings 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Output Problem 6 6
High Readings 6 6
Missing Information 6 6
Appropriate Term/Code Not Available 5 5
Device Operational Issue 5 5
Device Alarm System 4 4
Use of Device Problem 3 3
Low Test Results 3 3
Data Problem 3 3
Patient Data Problem 3 3
Insufficient Information 2 2
Application Program Problem 2 2
Low Readings 2 2
Defective Device 2 2
Device Markings/Labelling Problem 2 2
Computer Software Problem 2 2
False Positive Result 2 2
False Reading From Device Non-Compliance 2 2
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Premature Discharge of Battery 1 1
Microbial Contamination of Device 1 1
Output above Specifications 1 1
Product Quality Problem 1 1
Device Expiration Issue 1 1
False Negative Result 1 1
Physical Property Issue 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Displays Incorrect Message 1 1
Ambient Temperature Problem 1 1
Loss of Data 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 272 272
No Clinical Signs, Symptoms or Conditions 104 104
Hyperglycemia 24 24
No Consequences Or Impact To Patient 20 20
No Patient Involvement 14 14
Hypoglycemia 5 5
Insufficient Information 3 3
No Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Chemical Exposure 3 3
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Erythema 2 2
Injury 2 2
Unspecified Infection 1 1
Neuropathy 1 1
Rupture 1 1
Dry Eye(s) 1 1
Irritation 1 1
Swelling/ Edema 1 1
Test Result 1 1
Laceration(s) 1 1
Complaint, Ill-Defined 1 1
Red Eye(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 Abbott Laboratories II Oct-24-2014
5 Abbott Laboratories II May-29-2014
6 Abbott Point Of Care Inc. II Apr-01-2011
7 Bayer Healthcare, LLC II Aug-29-2015
8 Beckman Coulter Inc. II Nov-15-2016
9 Beckman Coulter Inc. II Mar-21-2012
10 Beckman Coulter Inc. II Jun-21-2011
11 Beckman Coulter Inc. III Aug-11-2010
12 Bio-Rad Laboratories, Inc. III Jun-25-2015
13 Biochemical Diagnostics Inc III Nov-23-2015
14 Helena Laboratories, Inc. III Nov-30-2018
15 Lifescan Inc II Apr-17-2013
16 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
17 Medline Industries Inc III Feb-19-2021
18 Microgenics Corporation II Jun-21-2013
19 Ortho-Clinical Diagnostics, Inc. III Jul-21-2023
20 Ortho-Clinical Diagnostics, Inc. III Nov-17-2021
21 Randox Laboratories Ltd. II Mar-15-2019
22 Sentinel CH SpA III Jul-06-2021
23 Siemens Healthcare Diagnostics, Inc II Feb-25-2017
24 Siemens Healthcare Diagnostics, Inc. II Feb-21-2023
25 Tosoh Bioscience Inc II Sep-14-2020
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