[pending] Syphilis Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0751-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Distribution without premarket approval/clearance.
The recalled product
- Product
- Syphilis 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: 7340221701656
- SKU: A-ISY
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27