Cepheid: Device Recall

Recall #Z-2584-2024 · 06/20/2024

Class II: Risk

Recall Details

Recall Number: Z-2584-2024
Classification: Class II
Product Type: Device
Recalling Firm: Cepheid
Status: Ongoing
Date Initiated: 06/20/2024
Location: Sunnyvale, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 651,150

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.

Product Description

Cepheid, Sample Collection Device, Part: 900-0370

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

Other Recalls by Cepheid

Class II: Risk 11/05/2025

Product testing did not meet expected stability criteria.
Class II: Risk 10/30/2025

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class II: Risk 10/30/2025

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class II: Risk 08/06/2025

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

View all recalls by Cepheid →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.