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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 11
AALTO SCIENTIFIC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 15
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD, DIAGNOSTICS GRP.
  SUBSTANTIALLY EQUIVALENT 2
BIOSITE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CLINIQA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CONE BIOPRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
EUROTROL B.V.
  SUBSTANTIALLY EQUIVALENT 2
FUJIREBIO DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
HELENA LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
MAINE STANDARDS CO.
  SUBSTANTIALLY EQUIVALENT 4
MAINE STANDARDS COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
MICROGENICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
QUALIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 5
RANDOX LABORATORIES, LTD.
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 5
SEBIA
  SUBSTANTIALLY EQUIVALENT 1
TECHNO-PATH MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 1
TECHNO-PATH MANUFACTURING LTD.
  SUBSTANTIALLY EQUIVALENT 4
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4
2016 13 13
2017 12 12
2018 7 7
2019 1 1
2020 7 7
2021 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 23 23
Human-Device Interface Problem 12 12
Improper or Incorrect Procedure or Method 3 3
Device Handling Problem 2 2
Nonstandard Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Use of Device Problem 2 2
Burst Container or Vessel 1 1
False Positive Result 1 1
High Test Results 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Human Factors Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 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
Laceration(s) 3 3
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Rash 1 1
Misdiagnosis 1 1
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1
Exposure to Body Fluids 1 1
Alteration In Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-16-2019
2 Abbott Point of Care Inc. II Feb-02-2011
3 Alere San Diego, Inc. II Nov-16-2016
4 Alere San Diego, Inc. III Oct-15-2015
5 Alere San Diego, Inc. III Jan-29-2013
6 Bio-rad Laboratories, Inc. III May-16-2013
7 Biosite Inc II Jun-11-2010
8 Biosite Inc Dba Innovacon Inc. II Nov-22-2010
9 Chromsystems Instruments & Chemicals GmbH II Jul-06-2022
10 Chromsystems Instruments & Chemicals GmbH II Dec-04-2020
11 Chromsystems Instruments & Chemicals GmbH II Dec-02-2020
12 Helena Laboratories, Inc. II Aug-30-2019
13 Horiba Instruments, Inc dba Horiba Medical III Feb-03-2014
14 Horiba Instruments, Inc dba Horiba Medical II Jan-31-2014
15 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
16 Medline Industries Inc II Sep-30-2020
17 Medtest Holdings, Inc. III Jun-08-2017
18 Medtest Holdings, Inc. III May-20-2017
19 MedtestDx, Inc. II Sep-15-2015
20 Microgenics Corporation II Dec-04-2014
21 Microgenics Corporation III Jun-26-2014
22 Microgenics Corporation III Nov-19-2012
23 Microgenics Corporation II Jan-11-2012
24 Ortho Clinical Diagnostics Inc III Nov-18-2020
25 Ortho Clinical Diagnostics Inc III Mar-01-2018
26 Ortho-Clinical Diagnostics II Mar-22-2024
27 Quantimetrix Corporation II Jan-17-2009
28 Randox Laboratories III Mar-12-2018
29 Randox Laboratories III May-26-2017
30 Randox Laboratories II Dec-14-2016
31 Randox Laboratories Ltd. II Sep-19-2023
32 Randox Laboratories Ltd. II Aug-23-2023
33 Randox Laboratories Ltd. III Jun-28-2023
34 Randox Laboratories Ltd. II Jan-05-2023
35 Randox Laboratories Ltd. II Mar-20-2020
36 Randox Laboratories Ltd. III Feb-06-2020
37 Randox Laboratories Ltd. II Jun-14-2019
38 Randox Laboratories Ltd. III Apr-08-2019
39 Randox Laboratories Ltd. II Mar-26-2019
40 Randox Laboratories Ltd. II Nov-03-2018
41 Randox Laboratories Ltd. II Jul-30-2018
42 Randox Laboratories Ltd. II Jun-13-2018
43 Randox Laboratories, Limited II Nov-15-2019
44 Randox Laboratories, Limited III Aug-07-2019
45 Randox Laboratories, Limited II Aug-06-2019
46 Randox Laboratories, Limited II Mar-09-2018
47 Response Biomedical Corp. II Mar-10-2020
48 Roche Diagnostics Corporation II May-31-2017
49 Siemens Healthcare Diagnostics, Inc. II Nov-16-2016
50 Siemens Healthcare Diagnostics, Inc. III Nov-13-2014
51 TECHNO-PATH MANUFACTURING LTD. II Oct-12-2023
52 Tosoh Bioscience Inc II May-14-2018
53 Utak Laboratories Inc III Jun-22-2020
54 Vital Diagnostics, Inc. II Apr-06-2010
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