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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, vitamin d
Regulation Description Vitamin D test system.
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 82
Non Reproducible Results 20
Adverse Event Without Identified Device or Use Problem 14
Incorrect Or Inadequate Test Results 12
Low Test Results 11
Mechanical Problem 7
Pump 3
Tube 3
Probe 3
Cell 2
Device Damaged Prior to Use 2
Washer 2
Unable to Obtain Readings 2
Mixer 2
Seal 1
Device Subassembly 1
Total Device Problems 167

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Qualigen Inc II Sep-07-2017
3 R & D Systems, Inc. III Nov-09-2018
4 Roche Diagnostics Corporation II Jul-08-2018
5 Siemens Healthcare Diagnostics, Inc II Nov-11-2016

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