Ortho-Clinical Diagnostics
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ortho-Clinical Diagnostics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-03FDA-DeviceClass IIVITROS Performance Verifier 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.
- 2024-04-03FDA-DeviceClass IIVITROS Performance Verifier I
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.
Get notified about new Ortho-Clinical Diagnostics recalls
Free weekly digest. We email when a new federal recall affects Ortho-Clinical Diagnostics or anything else in your household.
Get the Sunday Brief