Devices

CHOLESTEROL ASSAY

Model / Serial
Model Catalog: 225-26 (Lot serial: lot 37772)
Product Description
Cholesterol Assay Cat No.225-26
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
1 Event
- Recall of CHOLESTEROL ASSAY

Manufacturer

SEKISUI DIAGNOSTICS P.E.I. INC.

Manufacturer Address
CHARLOTTETOWN
Manufacturer Parent Company (2017)
Sekisui Chemical Co. Ltd.
Source
HC

5 devices with a similar name

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Beckman Coulter Cholesterol assay

Model / Serial
Model: OSR6X16, Affected: All lots
Manufacturer
Beckman Coulter Inc

Device Recall Beckman Coulter, Cholesterol Assay

Model / Serial
All Lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
Product Description
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Manufacturer
Beckman Coulter Inc.

Device Recall Boehringer Mannheim Cholesterol Assay

Model / Serial
Catalog Numbers: 11491458216; 11875540216; 11875523216.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Cholesterol CHOD-PAP. || In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Manufacturer
Roche Diagnostics Operations, Inc.

Device Recall Total Cholesterol Assay

Model / Serial
Catalog Numbers: 04718917190; 03039773190; 05168538190; 03039773190.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Cholesterol Gen.2. || The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.
Manufacturer
Roche Diagnostics Operations, Inc.

AEROSET SYSTEM - CHOLESTEROL ASSAY

Model / Serial
Model Catalog: 7D62-01 (Lot serial: 82099WH00); Model Catalog: 8D27-02 (Lot serial: 82101HW00)
Product Description
AEROSET CHOLESTEROL REAGENT KIT
Manufacturer
ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

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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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