International Medical Devices Database

Manufacturer Address
Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Rd, Jamestown NY 14701-9666
Manufacturer Parent Company (2017)
Trinity Biotech plc
Source
USFDA
2 Events
- Recall of Device Recall Captia Measles IgM
- Recall of Device Recall Captia (TM) Syphilis IgM Capture

2 devices in the database

Device Recall Captia Measles IgM

Model / Serial
Lot Number 2326060-043, Expiration Date 31 May 2017
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Distribution to US nationwide including California, and China (Hong Kong).
Product Description
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Device Recall Captia (TM) Syphilis IgM Capture

Model / Serial
Lot 033, expiry date 30 November 2014
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
New York, Florida, Utah, and California plus foreign distribution to Spain and France
Product Description
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

One manufacturer with a similar name

Learn more about the data here

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Manufacturer Address
Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
Manufacturer Parent Company (2017)
Trinity Biotech plc
Source
USFDA

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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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