International Medical Devices Database

9 devices in the database

RAPIDPoint® 500 System

Model / Serial
RAPIDPoint 500 Cartridge Serial Numbers Affected 10491449 RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) 2517102517 through 2519000012 See note below 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (400 tests) 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (250 tests) 10844813 RAPIDPoint 500 Measurement Cartridge Lactate (100 tests)

IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays

Model / Serial
3gAllergy™ Specific IgE Universal Kit IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 L2KUNJ6 10380875 10711939 Anti HBc IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 10381311 BR-MA (CA15-3) IMMULITE/IMMULITE 1000 LKBR1 10380948 BR-MA (CA15-3) IMMULITE 2000/IMMULITE 2000 XPi L2KBR2 10380983 CEA IMMULITE/IMMULITE 1000 LKCE1 10380945 CEA IMMULITE 2000/IMMULITE 2000 XPi L2KCE2 L2KCE6 10380994 10380995 CK-MB IMMULITE/IMMULITE 1000 LKMB1 10381016 CK-MB IMMULITE 2000/IMMULITE 2000 XPi L2KMB2 10381033 EPO IMMULITE/IMMULITE 1000 LKEPN1 10487627 EPO IMMULITE 2000/IMMULITE 2000 XPi L2KEPN2 L2KEPN6 10487628 10487629 SIEMENS Folic Acid IMMULITE 2000/IMMULITE 2000 XPi L2KFO2 L2KFO6 10380911 10380912 Gastrin IMMULITE/IMMULITE 1000 LKGA1 10380962 Gastrin IMMULITE 2000/IMMULITE 2000 XPi L2KGA2 10380979 OM-MA (CA125) IMMULITE/IMMULITE 1000 LKOP1 10380969 OM-MA (CA125) IMMULITE 2000/IMMULITE 2000 XPi L2KOP2 10380972 Thyroglobulin IMMULITE/IMMULITE 1000 LKTY1 10381644 Thyroglobulin IMMULITE 2000/IMMULITE 2000 XPi L2KTY2 10381648 Vitamin B12 IMMULITE/IMMULITE 1000 LKVB1 10380900 Reason for Correction Siemens Healthcare Diagnostics has confirmed through internal investigation that the IMMULITE ® /IMMULITE ® 1000/IMMULITE ® 2000/IMMULITE

Dimension Lipase

Model / Serial
Dimension® clinical chemistry system Positive Bias When Using Lipase (LIPL) Assay Lot FB8109

BCS®/ BCS® XP System

Model / Serial
BC Thrombin Reagent OWNA11 10446636 46751 2018-09-08 2016-11-01 BC Thrombin Reagent OWNA11 10446636 47184 2019-02-21 2017-03-20

Dimension® and Dimension Vista® Assays

Model / Serial

4 more

6 manufacturers with a similar name

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Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens AG
Source
AEMPSVFOI

Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens Ag
Manufacturers representative
ABDULREHMAN AL GOSAIBI GTB
Source
SFDA

Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens Ag
Source
BAM

Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens Ag
Source
AMPMDRS

Siemens Healthcare Diagnostics GmbH

Manufacturer Parent Company (2017)
Siemens Ag
Source
ORMPMDBP

One more

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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