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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device multi-analyte controls, all kinds (assayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJY
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
AALTO SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAINE STANDARDS COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 13 13
2017 12 12
2018 7 7
2019 1 1
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 23 23
Human-Device Interface Problem 11 11
Nonstandard Device 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Use of Device Problem 1 1
Output Problem 1 1
Device Handling Problem 1 1
Defective Device 1 1
Difficult to Open or Close 1 1
Human Factors Issue 1 1
False Positive Result 1 1
Label 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 31 31
No Known Impact Or Consequence To Patient 5 5
Injury 2 2
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Alteration In Body Temperature 1 1
No Information 1 1
Exposure to Body Fluids 1 1
Laceration(s) 1 1
Rash 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-16-2019
2 Alere San Diego, Inc. II Nov-16-2016
3 Alere San Diego, Inc. III Oct-15-2015
4 Helena Laboratories, Inc. II Aug-30-2019
5 Medline Industries Inc II Sep-30-2020
6 Medtest Holdings, Inc. III Jun-08-2017
7 Medtest Holdings, Inc. III May-20-2017
8 MedtestDx, Inc. II Sep-15-2015
9 Ortho Clinical Diagnostics Inc III Mar-01-2018
10 Randox Laboratories III Mar-12-2018
11 Randox Laboratories III May-26-2017
12 Randox Laboratories II Dec-14-2016
13 Randox Laboratories Ltd. II Mar-20-2020
14 Randox Laboratories Ltd. III Feb-06-2020
15 Randox Laboratories Ltd. II Jun-14-2019
16 Randox Laboratories Ltd. III Apr-08-2019
17 Randox Laboratories Ltd. II Mar-26-2019
18 Randox Laboratories Ltd. II Nov-03-2018
19 Randox Laboratories Ltd. II Jul-30-2018
20 Randox Laboratories Ltd. II Jun-13-2018
21 Randox Laboratories, Limited II Nov-15-2019
22 Randox Laboratories, Limited III Aug-07-2019
23 Randox Laboratories, Limited II Aug-06-2019
24 Randox Laboratories, Limited II Mar-09-2018
25 Response Biomedical Corp. II Mar-10-2020
26 Roche Diagnostics Corporation II May-31-2017
27 Siemens Healthcare Diagnostics, Inc. II Nov-16-2016
28 Tosoh Bioscience Inc II May-14-2018
29 Utak Laboratories Inc III Jun-22-2020
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