Cepheid: Medical Device Recall in 2024 - (Recall #: Z-2584-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Cepheid, Sample Collection Device, Part: 900-0370

Product Classification:

Class II

Date Initiated: June 20, 2024

Date Posted: August 21, 2024

Recall Number: Z-2584-2024

Event ID: 94932

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 651,150

Code Information:

UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025

Distribution Pattern:

Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Nicaragua, Germany, San Marino, Ecuador, New Caledonia, France, Austria, United Kingdom, Finland, Italy, Hong Kong, Kuwait, United Arab Emirates, Netherlands, Belgium, Monaco, Colombia, Spain, Portugal, Poland, Switzerland, Denmark, Jersey, Mexico

Voluntary or Mandated:

Voluntary: Firm initiated