FDA-Device2024-04-03Class II
VITROS Performance Verifier I
Ortho-Clinical Diagnostics
Hazard
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Affected count
10,911 units
Manufactured in
1000 Lee Rd, N/A, Rochester, NY, United States
Products
VITROS Performance Verifier I
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2024Don't want to check this manually?
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