Ortho-Clinical Diagnostics, Inc.: QMS Tacrolimus Calibrators Recalled for Degradation and Improper Storage

Agency Publication Date: January 11, 2024

Summary

Ortho-Clinical Diagnostics, Inc. is recalling 11 units of QMS Tacrolimus Calibrators (Lot 74859619) because the product was stored improperly. This storage error is expected to degrade the quality of the calibrator, making it unsuitable for medical testing. Use of these degraded calibrators can result in incorrect test results, which can cause significant delays in patient diagnosis and treatment.

Risk

The improper storage causes the chemical components of the calibrator to break down. If used, the device may provide inaccurate baseline measurements for Tacrolimus testing, potentially leading to incorrect medical decisions or the need for re-testing.

What You Should Do

Identify your supply by checking for QMS Tacrolimus Calibrators (Product code 10015573) with Lot number 74859619 and an expiration date of May 11, 2024.
Immediately stop using any calibrators from the affected lot (74859619) and sequester them to prevent accidental use.
Contact Ortho-Clinical Diagnostics, Inc. or your laboratory equipment supplier to report your possession of the affected units and to discuss replacement options.
Consult with your healthcare provider or laboratory supervisor if you believe previous test results may have been impacted by this specific lot of calibrators.
For more information or further instructions, contact the manufacturer, Ortho-Clinical Diagnostics, Inc., or call the FDA at 1-888-463-6332.

Your Remedy Options

Other Action

Cease use and contact manufacturer

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

Affected Products

Product: QMS Tacrolimus Calibrators, Product code 10015573

Model / REF:

10015573

Z-0712-2024

Lot Numbers:

74859619 (Exp 11-May-2024)

Date Ranges: May 11, 2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93621

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, Inc.

Sold By: authorized distributors

Manufactured In: United States

Units Affected: 10 sales units US; 1 sales unit OUS

Distributed To: Illinois, Indiana, Florida, New Jersey, New Mexico, Texas

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 supply by checking for QMS Tacrolimus Calibrators (Product code 10015573) with Lot number 74859619 and an expiration date of May 11, 2024.

Immediately stop using any calibrators from the affected lot (74859619) and sequester them to prevent accidental use.

Contact Ortho-Clinical Diagnostics, Inc. or your laboratory equipment supplier to report your possession of the affected units and to discuss replacement options.

Consult with your healthcare provider or laboratory supervisor if you believe previous test results may have been impacted by this specific lot of calibrators.

For more information or further instructions, contact the manufacturer, Ortho-Clinical Diagnostics, Inc., or call the FDA at 1-888-463-6332.