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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, human chorionic gonadotropin
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeDHA
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False Positive Result 188
High Test Results 177
Low Test Results 163
Adverse Event Without Identified Device or Use Problem 51
Mechanical Problem 32
False Negative Result 29
Incorrect Or Inadequate Test Results 12
Probe 11
Incorrect, Inadequate or Imprecise Result or Readings 5
Tube 4
Mixer 3
Device Issue 3
Cell 3
Non Reproducible Results 3
Seal 2
Device Subassembly 1
Clip 1
Washer 1
Unable to Obtain Readings 1
Device Damaged Prior to Use 1
Low Readings 1
Missing Value Reason 1
Use of Device Problem 1
Brush 1
Device Handling Problem 1
PC (Printed Circuit) Board 1
Incorrect Measurement 1
Device Operates Differently Than Expected 1
Adapter (Adaptor) 1
Spring 1
High Readings 1
Screw 1
Cover 1
Ring 1
Total Device Problems 705

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Ortho-Clinical Diagnostics II May-20-2016
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Tosoh Bioscience Inc II Jun-05-2018

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