Recall Z-1372-2024— Ortho-Clinical Diagnostics
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2024-02-27. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Performance Verifier I. Reason: 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..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-27
- Firm location
- Rochester, NY, United States
Product description
VITROS Performance Verifier I
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.