Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Code: 613

Product Code(s): LXG

Device Type ID	613
Device Name	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Regulation Description	General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
Regulation Medical Specialty	Clinical Chemistry
Review Panel	Clinical Chemistry
Premarket Review	Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type	510(K) Exempt
CFR Regulation Number	862.2050 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	LXG
GMP Exempt	Yes
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	613
Device	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Product Code	LXG
FDA Device Classification	Class 1 Medical Device
Regulation Description	General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
CFR Regulation Number	862.2050 [🔎]

Device Problems
Mechanical Problem	7
Insufficient Information	5
Break	4
False Negative Result	3
Device Operational Issue	3
Cups	2
Device Operates Differently Than Expected	2
Hole In Material	2
Guide	2
Detachment Of Device Component	2
Labelling, Instructions For Use Or Training Problem	2
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Incorrect Or Inadequate Test Results	1
Missing Value Reason	1
Low Test Results	1
Electrical Shorting	1
Device Contamination With Chemical Or Other Material	1
Material Deformation	1
Patient Data Problem	1
Holder	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	44

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics Inc.	II	Jun-29-2016
2	Siemens Healthcare Diagnostics, Inc.	II	Oct-23-2018
3	Siemens Medical Solutions Diagnostics	III	Jun-19-2014
4	Tecan US, Inc.	II	Aug-25-2016

TPLC Last Update: 2019-04-02 19:37:24