Device product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Z-1263-2026
Product summary
- Event
- Event 97801
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,800
- Official record key
device-enforcement:Z-1263-2026
Official wording
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Code information: Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
Distribution pattern: US Nationwide distribution in the states of TX, GA, CA.
Derived failure modes
-
Unknown
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.