Remel, Inc: Todd Hewitt Broth w/CNA (LIM) Recalled for Failure to Detect Target Bacteria

Agency Publication Date: September 8, 2023

Summary

Remel, Inc. is recalling 139 units (approximately 13,900 tests) of its Todd Hewitt Broth w/CNA (LIM Broth), a specialized laboratory product used to isolate Group B Streptococci from patient clinical samples. The recall was initiated because one specific lot of the broth may fail to grow the target bacteria during quality control testing or when processing patient samples. This defect was identified during customer testing and could lead to inaccurate laboratory results.

Risk

If the broth fails to recover the target organism, it could result in a false-negative test for Group B Streptococci, potentially leading to a delay in diagnosis or improper treatment for patients.

What You Should Do

Check your laboratory inventory for remel TODD HEWITT W. CNA (LIM BROTH) with Reference Number R064810.
Verify if your product belongs to lot number 668255 with an expiration date of 04/26/2024 and UDI/DI 00848838010064.
Immediately stop using any broth from the affected lot (668255) for clinical specimens or quality control testing.
Contact your healthcare provider or laboratory supervisor to discuss the impact on any previous tests performed with this specific lot.
Contact Remel, Inc. (Thermo Fisher Scientific) at their Lenexa, Kansas facility or through your primary sales representative to arrange for a replacement or further instructions.
For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and corrective action

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

Affected Products

Product: remel TODD HEWITT W. CNA (LIM BROTH), REF R064810 (139 units/13,900 tests)

Model / REF:

REF R064810

UPC Codes:

00848838010064

Lot Numbers:

668255 (Exp. 04/26/2024)

Date Ranges: 04/26/2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92880

Status: Active

Manufacturer: Remel, Inc

Sold By: Laboratory distributors; Direct sales from Remel, Inc.

Manufactured In: United States

Units Affected: 139 units (13,900 tests)

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

Check your laboratory inventory for remel TODD HEWITT W. CNA (LIM BROTH) with Reference Number R064810.

Verify if your product belongs to lot number 668255 with an expiration date of 04/26/2024 and UDI/DI 00848838010064.

Immediately stop using any broth from the affected lot (668255) for clinical specimens or quality control testing.

Contact your healthcare provider or laboratory supervisor to discuss the impact on any previous tests performed with this specific lot.

Contact Remel, Inc. (Thermo Fisher Scientific) at their Lenexa, Kansas facility or through your primary sales representative to arrange for a replacement or further instructions.

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