FDA-Device2020-11-25Class II
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Ortho Clinical Diagnostics Inc
Hazard
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
Affected count
651 units
Manufactured in
1001 US Highway 202, N/A, Raritan, NJ, United States
Products
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0450-2021Don't want to check this manually?
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