FDA-Device2023-11-08Class II
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Cepheid
Hazard
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Sold states
Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
Affected count
89,958 kits ( 10 test per kit)
Manufactured in
904 E Caribbean Dr, N/A, Sunnyvale, CA, United States
Products
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0215-2024Don't want to check this manually?
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