FDA Enforcement
Class II
Ongoing
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Recall: Z-0216-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0216-2024
- Event ID
- 93125
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cepheid
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- April 24, 2023
- Classification Date
- November 2, 2023
- Address
- 904 E Caribbean Dr, N/A, Sunnyvale, CA, 94089-1189, United States
Description
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
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 Info
UDI: (01)07332940006297/ Lot: 23815
Distribution
Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
Quantity
1,413 kits ( 10 test per kit)