Ortho-Clinical Diagnostics: VITROS Performance Verifier Kits Recalled for Erroneous Test Results

Agency Publication Date: March 22, 2024

Summary

Ortho-Clinical Diagnostics is recalling 22,135 units of VITROS Chemistry Products Performance Verifier I and II after discovering that mismatched diluent lots were assembled into the kits. This defect can cause incorrect Quality Control results, specifically showing higher or lower than actual levels of sodium and total carbon dioxide. If these errors go undetected, they can lead to significant delays in medical testing or the delivery of erroneous results to patients. These kits were distributed worldwide between February and March 2024.

Risk

The mismatched liquid component causes a measurement bias of up to 6 mmol/L for sodium and carbon dioxide tests, which can lead healthcare providers to make incorrect clinical decisions or delay necessary patient treatments.

What You Should Do

Identify your product by checking the packaging for VITROS Performance Verifier I (Product Code 8067324) with Lot Number Q1174 and GTIN 10758750004317.
Identify your product by checking the packaging for VITROS Performance Verifier II (Product Code 8231474) with Lot Number R1176 and GTIN 10758750004577.
Immediately stop using any Performance Verifier kits from the affected lots for Quality Control testing.
Contact your healthcare provider or Ortho-Clinical Diagnostics at their Rochester, New York headquarters to discuss how this may affect previous lab results and to arrange for replacements or further instructions.
Call the FDA's medical device recall hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

Manufacturer and Healthcare Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VITROS Performance Verifier I

Model / REF:

8067324

UPC Codes:

10758750004317

Lot Numbers:

Q1174

Product: VITROS Performance Verifier II

Model / REF:

8231474

UPC Codes:

10758750004577

Lot Numbers:

R1176

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94174

Status: Active

Manufacturer: Ortho-Clinical Diagnostics

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 2 products (10,911 units; 11,224 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product by checking the packaging for VITROS Performance Verifier I (Product Code 8067324) with Lot Number Q1174 and GTIN 10758750004317.

Identify your product by checking the packaging for VITROS Performance Verifier II (Product Code 8231474) with Lot Number R1176 and GTIN 10758750004577.

Immediately stop using any Performance Verifier kits from the affected lots for Quality Control testing.

Contact your healthcare provider or Ortho-Clinical Diagnostics at their Rochester, New York headquarters to discuss how this may affect previous lab results and to arrange for replacements or further instructions.

Call the FDA's medical device recall hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.