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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
  1.  K122838  LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL ...
  2.  K123198  LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 27 ...
  3.  K123663  LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL ...
  4.  K123775  LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK ...
  5.  K130162  LIQUID ASSAYED MULTIQUAL PREMIUM
  6.  K130761  LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVE ...
  7.  K132227  LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LI ...
  8.  K133960  LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
  9.  K134013  LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCH ...
  10.  K140764  LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL ...
  11.  K140916  LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AN ...
  12.  K141073  LIQUICHEK TUMOR MARKER CONTROL
  13.  K143379  Liquichek Maternal Serum II Control
  14.  K150300  Liquichek Cardiac Markers Plus Control LT
  15.  K163015  Liquichek Tumor Marker Control-Level 1; Liquichek ...
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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