Date Recall |
March 28, 2006 |
Product: |
VITROS® Immunodiagnostic Products Signal Reagent, Lot 8350, catalog #107 2693 |
Use: |
This reagent is a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy. |
Recalling Firm: |
Ortho-Clinical Diagnostics |
Reason for Recall: |
A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests. |
Public Contact: |
Judy M. Strzepek |
FDA District: |
New York Downstate |
FDA Comments: |
|
|
A copy of Ortho-Clinical Diagnostics’ (a Johnson & Johnson company) press release about this recall can be found on the company’s website. |
Updated April 18, 2006
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH