Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cepheid Recalled by Cepheid Due to Specimen collection device may leak after the patient...

Date: June 20, 2024
Company: Cepheid
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.

Affected Products

Cepheid, Sample Collection Device, Part: 900-0370

Quantity: 651,150

Why Was This Recalled?

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cepheid

Cepheid has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report