규제 업데이트

Trinity Biotech is recalling Oxalate Reagent B (Product Code 591-2, Lot 2500711) due to performance variability that may produce falsely low oxalate results. Users should stop use and quarantine inventory.

Health Canada has recalled Platinum Naturals Easymulti Stress (Men) capsules (lots 737‑737C) due to incorrect Vitamin B6 labeling. Retailers should remove affected products.

Health Canada has recalled three Organika gummy supplements after discovering they were imported from a foreign manufacturing site not listed on the site licence.

Yuyu Pharmaceutical re‑shipped four voluntarily recalled items, including Tanamin tablets, before official recall closure, prompting the MFDS to impose a 15‑day manufacturing halt. The action was due to procedural lapses, not product safety.

Teva Canada is recalling a lot of Novo‑Gesic Forte 500 mg acetaminophen tablets due to possible phenolic resin or epoxy contamination that could injure the digestive system.

GE Healthcare reports two potential safety issues affecting order and recording summary components in certain Centricity High Acuity systems.

Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.

Philips reports a software fault in MR systems (versions R5 & R11) that can freeze the system during image reconstruction, requiring a restart.

Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.

Boston Scientific is recalling Imager II Angiographic Catheters after discovering reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.

Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.

Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.