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VITROS Performance Verifier I

FDA Recall #Z-1372-2024 — Class II — February 27, 2024

Recall #Z-1372-2024 Date: February 27, 2024 Classification: Class II Status: Ongoing

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.

Recalling Firm

Ortho-Clinical Diagnostics — Rochester, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

Code Information

Product Code: 8067324; GTIN: 10758750004317; Lot No. Q1174.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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