IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG KIT 200T TOXOPLASMA QUANTITATIVE IGG ASSAY (TXP) L2KTXP2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG KIT 200T TOXOPLASMA QUANTITATIVE IGG ASSAY (TXP) L2KTXP2 manufactured by Siemens Healthcare Diagnostics Products, Limited.

MAUDE Entry Details

Report Number2432235-2019-00333
MDR Report Key9125532
Date Received2019-09-26
Date of Report2019-10-28
Date of Event2019-07-11
Date Mfgr Received2019-10-15
Date Added to Maude2019-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MIR KHAN
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10951
Manufacturer CountryUS
Manufacturer Postal10951
Manufacturer Phone9145243074
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetGLYN RHONWY UK REGISTRATION #: 3002806944
Manufacturer CityLLANBERIS, LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG KIT 200T
Generic NameTOXOPLASMA QUANTITATIVE IGG ASSAY (TXP)
Product CodeLGD
Date Received2019-09-26
Model NumberTOXOPLASMA QUANTITATIVE IGG ASSAY (TXP)
Catalog NumberL2KTXP2
Lot Number446
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer AddressGLYN RHONWY LLANBERIS, LL554EL UK LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-26

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