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TPLC
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Device
system, test, human chorionic gonadotropin
Product Code
DHA
Regulation Number
862.1155
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
DIAZYME LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN YHLO BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
152
152
2020
115
115
2021
210
210
2022
185
185
2023
199
199
2024
226
226
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
556
556
High Test Results
304
304
Low Test Results
113
113
Non Reproducible Results
99
99
False Negative Result
66
66
Incorrect, Inadequate or Imprecise Result or Readings
45
45
Incorrect Measurement
19
19
No Apparent Adverse Event
5
5
Output Problem
4
4
High Readings
3
3
Low Readings
3
3
Material Integrity Problem
2
2
Unable to Obtain Readings
2
2
Chemical Problem
1
1
Insufficient Information
1
1
Erratic Results
1
1
Data Problem
1
1
Product Quality Problem
1
1
Failure to Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
781
781
No Known Impact Or Consequence To Patient
178
178
No Consequences Or Impact To Patient
43
43
Abdominal Pain
19
19
No Information
14
14
Nausea
10
10
Insufficient Information
8
8
Vomiting
7
7
Pain
6
6
No Patient Involvement
5
5
Headache
4
4
Anxiety
4
4
Misdiagnosis
3
3
Diarrhea
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Code Available
3
3
Decreased Appetite
2
2
Intermenstrual Bleeding
2
2
Test Result
2
2
Ectopic Pregnancy
2
2
Numbness
2
2
Cyst(s)
2
2
Lupus
2
2
Memory Loss/Impairment
1
1
Weakness
1
1
Syncope
1
1
Unspecified Infection
1
1
Decreased Respiratory Rate
1
1
Sleep Dysfunction
1
1
Dyskinesia
1
1
Dysphasia
1
1
Complete Induced Abortion
1
1
Edema
1
1
Fever
1
1
Abscess
1
1
Anemia
1
1
Stroke/CVA
1
1
Chest Pain
1
1
Congestive Heart Failure
1
1
Renal Disease, End Stage
1
1
Sepsis
1
1
Septic Shock
1
1
Spinal Column Injury
1
1
Swelling
1
1
Vertigo
1
1
Visual Impairment
1
1
Dysuria
1
1
Lymphoma
1
1
Hallucination
1
1
Cough
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
III
Jan-17-2023
2
Siemens Healthcare Diagnostics, Inc.
II
Apr-28-2022
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