🍔 Food 💊 Drugs 🏥 Medical Devices
Diabetes HbA1c Test Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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D-Dimer Test Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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Chlamydia Test Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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Candida Test Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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Blood Type Test Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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Alcohol (ALC) Test Saliva Class II

Reason: Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB 20251103 Ongoing
Distributed: US Nationwide distribution.
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Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 Class II

Reason: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Medtronic, Inc. 20251029 Ongoing
Distributed: Worldwide - US Nationwide distribution.
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InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. Class II

Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Enterix, Inc. 20250917 Ongoing
Distributed: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.
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IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. Class I

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

Fresenius Kabi USA, LLC 20251103 Ongoing
Distributed: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
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Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Class II

Reason: Product testing did not meet expected stability criteria.

Cepheid 20251105 Ongoing
Distributed: US Nationwide distribution and Puerto Rico.
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