Cepheid: Sample Collection Device Recalled for Potential Biohazard Leakage

Agency Publication Date: August 14, 2024

Summary

Cepheid is recalling 651,150 Sample Collection Devices (Part: 900-0370) because the test tubes may leak after a patient sample has been inserted. This defect can lead to biohazard exposure for healthcare workers, cross-contamination between samples, or delays in receiving medical results. These devices were distributed nationwide and internationally between 2023 and 2024. If you have these devices, contact your healthcare provider or the manufacturer for guidance on safe handling and potential replacement.

Risk

Leaking test tubes can expose individuals to infectious biological materials and contaminate other nearby samples, which may lead to incorrect test results or a spread of pathogens.

What You Should Do

Identify if you have the Cepheid Sample Collection Device (Part: 900-0370) by checking the packaging for UDI-DI 28053326001523.
Check your device for the following affected lot numbers and expiration dates: Lot 230397900 (Exp July 3, 2024), Lot 230535300 (Exp July 14, 2024), Lot 230627500 (Exp August 4, 2024), or Lot 231877400 (Exp April 10, 2025).
Exercise extreme caution when handling these specific lots to avoid skin or surface contact with leaked specimen fluids.
Contact Cepheid directly or your healthcare provider for further instructions regarding the disposal or return of affected units and to discuss potential refunds or replacements.
For more 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

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

Affected Products

Product: Cepheid Sample Collection Device, Part: 900-0370

Model / REF:

900-0370

Lot Numbers:

230397900 (Exp July 3, 2024)

230535300 (Exp July 14, 2024)

230627500 (Exp August 4, 2024)

231877400 (Exp April 10, 2025)

Date Ranges: July 3, 2024, July 14, 2024, August 4, 2024, April 10, 2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94932

Status: Active

Manufacturer: Cepheid

Sold By: Authorized distributors; Healthcare facilities

Manufactured In: United States

Units Affected: 651,150

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

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 Cepheid Sample Collection Device (Part: 900-0370) by checking the packaging for UDI-DI 28053326001523.

Check your device for the following affected lot numbers and expiration dates: Lot 230397900 (Exp July 3, 2024), Lot 230535300 (Exp July 14, 2024), Lot 230627500 (Exp August 4, 2024), or Lot 231877400 (Exp April 10, 2025).

Exercise extreme caution when handling these specific lots to avoid skin or surface contact with leaked specimen fluids.

Contact Cepheid directly or your healthcare provider for further instructions regarding the disposal or return of affected units and to discuss potential refunds or replacements.

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