Cepheid Xpert Xpress Strep A test kits may produce invalid results
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a functional defect that could result in invalid or missed test results, creating a risk of diagnostic failure and potential missed diagnoses of Strep A infection.
Plain-English summary
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits (Lot 23815) worldwide, including distribution across the United States, Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, and United Arab Emirates.
The recall is due to a defect affecting the pipettes packaged with the test kits. These pipettes may fail to dispense an adequate volume of sample material. When this occurs, the test may produce invalid results or no test result at all, potentially preventing proper diagnosis of Strep A infection.
Users of affected test kits should immediately discontinue use of any remaining tests from Lot 23815. Healthcare providers and laboratories should contact Cepheid directly for information on replacement kits or alternative testing procedures. Any tests already conducted using pipettes from affected kits should be reviewed for validity, and patients may need retesting to ensure accurate diagnosis.
The recalled product
- Product
- Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
- Manufacturer
- Cepheid
- Category
- Medical Device — Diagnostic Test
- Hazard
- pipette-defect
- invalid-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)07332940006297/ Lot: 23815
Distribution
Distributed nationwide across the United States.
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