Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)07332940006297/ Lot: 23815
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cepheid
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Product Codes/Lot Numbers:
UDI: (01)07332940006297/ Lot: 23815
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0216-2024
Related Recalls
Product testing did not meet expected stability criteria.
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.