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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of TX, GA, CA. Quantity: 1,000 Lot/code info: Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.