stop use immediately Recalls

GET TESTED INTERNATIONAL AB Recalls Candida Test for Lack of Approval

GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.

GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)

Distribution without premarket approval/clearance.

Nissan Recalls 2025 Sentra for Driver Seat Frame Security Issue

GET TESTED INTERNATIONAL AB Sperm Test Recall for Premarket Violation (2025)

Distribution without premarket approval/clearance.

Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues

Labeling contains claims that are not consistently present.

GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Adrenal Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues

Labeling contains claims that are not consistently present.

GET TESTED INTERNATIONAL AB HbA1c Diabetes Test Recall Expands Nationwide (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Urinary Tract Infection Test Due to Approval Issues

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls 3 Food Sensitivity Test Small Units in 2025

Distribution without premarket approval/clearance.

Orthofix Recalls PTC Spacer Systems Over Labeling Issues

Labeling contains claims that are not consistently present.

Fresenius Kabi USA Recalls 483 LVP Infusion Sets for IVENIX System Over Incorrect Assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

GET TESTED INTERNATIONAL AB Recalls Allergy Test IgE Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB Issues Recall for Pet Allergy Test

GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB Issues Recall of Alcohol Test Kit

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Chlamydia Test Recall 2026 — 5 US Units Distributed, PMA Issue

Distribution without premarket approval/clearance.

Orthofix Recalls Ti Spacer System Due to Labeling Issues

Labeling contains claims that are not consistently present.