Z-0216-2024 Class II Ongoing
FDA device recall Z-0216-2024 was initiated by Cepheid on April 24, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 1,413 kits ( 10 test per kit).
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- April 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,413 kits ( 10 test per kit)
Product Description
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Reason for Recall
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.
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.
Code Information
UDI: (01)07332940006297/ Lot: 23815