VITROS Performance Verifier I
Reported: April 3, 2024 Initiated: February 27, 2024 #Z-1372-2024
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 10,911 units
- Distribution
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Performance Verifier I. Recalled by Ortho-Clinical Diagnostics. Units affected: 10,911 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1372-2024.
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