2 in 1 Trichomonas / Gardnerella Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0816-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Distribution without premarket approval/clearance.
The recalled product
- Product
- 2 in 1 Trichomonas / Gardnerella Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Devices
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 (4)
- EAN: 7340221700925
- SKU: B-TOG
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
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