Cepheid Xpert Xpress Strep A test kits may produce invalid results
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
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 Class II medical device recall involves a diagnostic test for Strep A, a significant pathogen. The pipette malfunction could result in invalid or missed test results, potentially preventing proper diagnosis and treatment. No illnesses or injuries have been reported from this specific device failure.
Plain-English summary
Cepheid is recalling the Xpert Xpress Strep A diagnostic test kits (model XPRSTREPA-10, part number 302-2294) because the pipettes used in the test may fail to dispense an adequate volume of sample. When pipettes malfunction, the test can produce invalid results or no result.
The recall affects 89,958 kits distributed worldwide, including throughout the United States and internationally to Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, and United Arab Emirates. Affected lot numbers are identified in the FDA recall notice.
Patients who have received test results from these kits should consult with their healthcare provider to determine whether retesting is necessary. Healthcare facilities should verify the lot numbers of their test kits and take appropriate action if they have affected units.
The recalled product
- Product
- Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
- Manufacturer
- Cepheid
- Category
- Medical Device — Diagnostic Test
- Hazard
- test-failure
- invalid-results
- false-negative-risk
Distribution
Distributed nationwide across the United States.
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