Device product
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Z-0216-2024
Product summary
- Firm
- Cepheid
- Event
- Event 93125
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,413 kits ( 10 test per kit)
- Official record key
device-enforcement:Z-0216-2024
Official wording
Reason: 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.
Code information: UDI: (01)07332940006297/ Lot: 23815
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
Derived failure modes
-
Unknown
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.