Ortho-Clinical Diagnostics: Medical Device Recall in 2024 - (Recall #: Z-1373-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
VITROS Performance Verifier II
Class II
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.
Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.
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.
Voluntary: Firm initiated
