Recall archive / FDA device enforcement
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, — FDA record Z-0216-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Cepheid
- Quantity
- 1,413 kits ( 10 test per kit)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0216-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)07332940006297/ Lot: 23815 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 8, 2023
- Recall initiation date
- Apr 24, 2023
- Center classification date
- Nov 2, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.