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TPLC
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show TPLC since
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Device
radioimmunoassay, prolactin (lactogen)
Product Code
CFT
Regulation Number
862.1625
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
6
6
2017
18
18
2018
27
27
2019
12
12
2020
20
20
2021
23
23
2022
29
29
2023
28
28
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
130
130
Low Test Results
34
34
Incorrect Or Inadequate Test Results
11
11
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Incorrect Measurement
7
7
Non Reproducible Results
5
5
Insufficient Information
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Leak/Splash
1
1
Separation Failure
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
97
97
No Known Impact Or Consequence To Patient
53
53
No Consequences Or Impact To Patient
29
29
No Code Available
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Apr-20-2011
2
Ortho Clinical Diagnostics Inc
II
Oct-03-2018
3
Ortho-Clinical Diagnostics, Inc
II
May-18-2022
4
Siemens Healthcare Diagnostics, Inc
III
Sep-19-2012
5
Siemens Healthcare Diagnostics, Inc.
II
May-05-2017
6
Tosoh Bioscience Inc
II
Jun-05-2018
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