GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Recalled for 3 Units in 2025
Distribution without premarket approval/clearance.
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High activity category
This category has a significant number of recalls. Check it regularly if you own products in this area.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.
Distribution without premarket approval/clearance.