FDAFDA · Food and drugs·Recall number Z-2584-2024
Cepheid, Sample Collection Device, Part: 900-0370
Published August 21, 2024 · Recall initiated: June 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cepheid
- Distributor
- 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
- Lot
- UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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