Menopause (FSH) 2 Tests
Reported: December 10, 2025 Initiated: November 3, 2025 #Z-0744-2026
Product Description
Menopause (FSH) 2 Tests
Reason for Recall
Distribution without premarket approval/clearance.
Details
- Recalling Firm
- GET TESTED INTERNATIONAL AB
- Units Affected
- 184 units
- Distribution
- US Nationwide distribution.
- Location
- Vastervik
Frequently Asked Questions
What product was recalled? ▼
Menopause (FSH) 2 Tests. Recalled by GET TESTED INTERNATIONAL AB. Units affected: 184 units.
Why was this product recalled? ▼
Distribution without premarket approval/clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0744-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11