Blog – Page 2 – PRAIS 2.0

Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Murilo Freitas - 05:00, 14 de January de 2026217

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-initiates-medical-device-correction-certain-freestyle-librer-3-and-freestyle-libre-3-plus

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Drug use disorders a growing public health concern in the Americas, PAHO study finds

admin - 14:25, 13 de January de 202672

Drug use disorders a growing public health concern in the Americas, PAHO study finds

Cristina Mitchell

14 Jan 2026

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Early Alert: Dialysis Tubing Set Issue from Vantive

Murilo Freitas - 05:00, 13 de January de 2026148

Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-dialysis-tubing-set-issue-vantive

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FDA Approves First Treatment for Children With Menkes Disease

Murilo Freitas - 22:00, 11 de January de 2026118

FDA Approves First Treatment for Children With Menkes Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-children-menkes-disease

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FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

Murilo Freitas - 14:39, 11 de January de 2026316

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
http://www.fda.gov/news-events/press-announcements/fda-issues-guidance-modernizing-statistical-methods-clinical-trials

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FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

Murilo Freitas - 20:03, 10 de January de 2026455

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
http://www.fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation

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PAHO issues alert on simultaneous circulation of seasonal influenza and respiratory syncytial virus in the Americas

admin - 02:24, 10 de January de 2026183

PAHO issues alert on simultaneous circulation of seasonal influenza and respiratory syncytial virus in the Americas

Cristina Mitchell

10 Jan 2026

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Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Murilo Freitas - 05:00, 8 de January de 2026479

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for management of osteoarthritis

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/anthony-trinh-123herbals-llc-123herbalscom-issues-nationwide-recall-silintan-capsules-due-presence

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Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits

Murilo Freitas - 05:00, 8 de January de 2026102

AVID is removing bags from Organ Recovery and Medical Convenience Kits due to the bags being made of non-medical grade Poly and lacking intact seals.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/organ-recovery-pack-correction-avid-medical-issues-correction-medical-convenience-and-organ-recovery

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Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.

Murilo Freitas - 05:00, 8 de January de 2026618

[Phoenix, Arizona] – [12/22/25] – Modern Warrior is voluntarily recalling all lots of Modern Warrior Ready, a dietary supplement sold directly to consumers, after regulatory testing identified the presence of undeclared ingredients, including tianeptine, 1,4-DMAA, and aniracetam..Tianeptine can c

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/modern-warrior-recalls-modern-warrior-ready-dietary-supplement-due-undeclared-14-dmaa-and-aniracetam