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TPLC
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Device
test, qualitative and quantitative factor deficiency
Product Code
GGP
Regulation Number
864.7290
Device Class
2
Premarket Reviews
Manufacturer
Decision
DIAGNOSTICA STAGO, INC.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
4
INSTRUMENTATION LABORATORY COMPANY
SUBSTANTIALLY EQUIVALENT
1
PRECISION BIOLOGIC
SUBSTANTIALLY EQUIVALENT
1
PRECISION BIOLOGIC INC.
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2017
3
3
2018
3
3
2019
1
1
2021
2
2
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
5
5
High Test Results
4
4
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Off-Label Use
1
1
Insufficient Information
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
8
8
No Clinical Signs, Symptoms or Conditions
6
6
No Information
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
American Diagnostica, Inc.
II
Apr-21-2010
2
Aniara Diagnostica LLC
II
Mar-06-2023
3
Diagnostica Stago, Inc.
II
Apr-10-2020
4
Helena Laboratories, Inc.
II
Oct-12-2018
5
Instrumentation Laboratory Co.
II
Feb-01-2016
6
Instrumentation Laboratory Co.
II
May-10-2012
7
Sekisui Diagnostics Llc
II
Dec-03-2012
8
Sekisui Diagnostics Llc
II
Sep-20-2012
9
Siemens Healthcare Diagnostics, Inc.
II
Dec-22-2015
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