Beckman Coulter Inc.: IgA Reagent Kits Recalled Due to Performance Specification Failure

Agency Publication Date: August 31, 2023

Summary

Beckman Coulter Inc. has recalled 12,850 units of its IgA reagent kits, specifically the IVD REF: OSR61171 model. This recall was initiated because the product's lipemic interference (how fat in a blood sample affects test results) failed to meet the performance specifications listed in the Instructions for Use. This failure can lead to inaccurate diagnostic results for patients. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this diagnostic device.

Risk

The device fails to properly account for fatty substances in blood samples, which may lead to incorrect measurement of IgA levels. This inaccuracy could result in a healthcare provider making incorrect clinical decisions based on flawed lab data.

What You Should Do

Identify if you have the affected product by checking for Beckman Coulter IVD, REF: OSR61171, IgA with UDI (01)15099590011574.
Review your inventory for any kits matching the reference number OSR61171, as all lots are affected by this recall.
If you are a laboratory or healthcare professional using this reagent, contact Beckman Coulter Inc. immediately to discuss the impact on your testing performance and to receive updated technical guidance.
Patients who have recently had IgA testing performed using Beckman Coulter equipment should contact their healthcare provider if they have concerns about the accuracy of their results.
Contact Beckman Coulter Inc. at their Brea, California facility or via their official website for further instructions regarding a potential remedy or replacement.
For additional information, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for technical guidance and potential remedy.

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

Affected Products

Product: Beckman Coulter, IVD, REF: OSR61171, IgA (4 x 14 mL R1, 4 x 11 mL R2)

Model / REF:

OSR61171

UPC Codes:

15099590011574

Lot Numbers:

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92729

Status: Active

Manufacturer: Beckman Coulter Inc.

Sold By: Medical laboratories; Healthcare facilities

Manufactured In: United States

Units Affected: 12,850 units

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

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 if you have the affected product by checking for Beckman Coulter IVD, REF: OSR61171, IgA with UDI (01)15099590011574.

Review your inventory for any kits matching the reference number OSR61171, as all lots are affected by this recall.

If you are a laboratory or healthcare professional using this reagent, contact Beckman Coulter Inc. immediately to discuss the impact on your testing performance and to receive updated technical guidance.

Patients who have recently had IgA testing performed using Beckman Coulter equipment should contact their healthcare provider if they have concerns about the accuracy of their results.

Contact Beckman Coulter Inc. at their Brea, California facility or via their official website for further instructions regarding a potential remedy or replacement.

For additional information, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.