FDA-Device2024-08-21Class II
Cepheid, Sample Collection Device, Part: 900-0370
Cepheid
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.
Sold states
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
Affected count
651,150
Manufactured in
904 E Caribbean Dr, Sunnyvale, CA, United States
Products
Cepheid, Sample Collection Device, Part: 900-0370
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2584-2024Don't want to check this manually?
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