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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multi-analyte controls, all kinds (assayed)
Product CodeJJY
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
AALTO SCIENTIFIC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
TECHNO-PATH MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 7 7
2019 1 1
2020 7 7
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 10 10
Human-Device Interface Problem 10 10
Nonstandard Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
False Positive Result 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Device Handling Problem 1 1
High Test Results 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Human Factors Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 4 4
No Information 1 1
Insufficient Information 1 1
Needle Stick/Puncture 1 1
Alteration In Body Temperature 1 1
Rash 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-16-2019
2 Chromsystems Instruments & Chemicals GmbH II Jul-06-2022
3 Chromsystems Instruments & Chemicals GmbH II Dec-04-2020
4 Chromsystems Instruments & Chemicals GmbH II Dec-02-2020
5 Helena Laboratories, Inc. II Aug-30-2019
6 Medline Industries Inc II Sep-30-2020
7 Medtest Holdings, Inc. III Jun-08-2017
8 Medtest Holdings, Inc. III May-20-2017
9 Ortho Clinical Diagnostics Inc III Nov-18-2020
10 Ortho Clinical Diagnostics Inc III Mar-01-2018
11 Randox Laboratories III Mar-12-2018
12 Randox Laboratories III May-26-2017
13 Randox Laboratories Ltd. II Jan-05-2023
14 Randox Laboratories Ltd. II Mar-20-2020
15 Randox Laboratories Ltd. III Feb-06-2020
16 Randox Laboratories Ltd. II Jun-14-2019
17 Randox Laboratories Ltd. III Apr-08-2019
18 Randox Laboratories Ltd. II Mar-26-2019
19 Randox Laboratories Ltd. II Nov-03-2018
20 Randox Laboratories Ltd. II Jul-30-2018
21 Randox Laboratories Ltd. II Jun-13-2018
22 Randox Laboratories, Limited II Nov-15-2019
23 Randox Laboratories, Limited III Aug-07-2019
24 Randox Laboratories, Limited II Aug-06-2019
25 Randox Laboratories, Limited II Mar-09-2018
26 Response Biomedical Corp. II Mar-10-2020
27 Roche Diagnostics Corporation II May-31-2017
28 Tosoh Bioscience Inc II May-14-2018
29 Utak Laboratories Inc III Jun-22-2020
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