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Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

Moderate

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

FentaNYL and Ropivacaine (Apollo Care) – Sterility Issue (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAApr 15, 2025MO• Apollo Care, LLC

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Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

FentaNYL and Ropivacaine (Apollo Care) – Sterility Issue (2025)

Cooper Discoverer Tire (Cooper) – Identification Number (2025)

Audi RS E-Tron GT (Audi) – Passenger Detection (2025)

ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Oshkosh NGDV (Oshkosh) – Rearview Camera (2025)

Straumann Initial Drill (Straumann) – Laser Engraving (2025)

Prevost H3-45 (Prevost) – Emergency Exit Issue (2025)

VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Forest River Cascade (Forest River) – Step Assembly (2025)

Maserati Granturismo (Maserati) – Tire Label (2025)

Augmedics Perc Pin Adaptor (Augmedics) – Tightening Marking (2025)

Male Ultra Pro (SAINI TRADE) – Undeclared Ingredients (2025)

Ultra Armor (SAINI TRADE) – Undeclared Ingredients (2025)

Glidewell HT Implant Drill (Prismatik) – Packaging Mixup (2025)

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

Male Ultra (SAINI TRADE) – Undeclared Ingredients (2025)

Electro Buzz (SAINI TRADE) – Undeclared Ingredients (2025)

Cilantro Salsa (MegaMex Foods) – foreign wood pieces (2025)

Malextra Supplement (SAINI TRADE) – Undeclared Ingredients (2025)