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SymphoKnee Femoral Augment (Linkbio) – Incorrect Implant (2023)

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

FDAApr 25, 2023Nationwide• Linkbio Corp.

FilmArray GI Panel (BioFire) – False Positive Risk (2023)

Fire/Burn Risk

The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDAApr 25, 2023AL, AK, AZ +49 more• BioFire Diagnostics, LLC

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SymphoKnee Femoral Augment (Linkbio) – Incorrect Implant (2023)

FilmArray GI Panel (BioFire) – False Positive Risk (2023)

Ventralight ST Ellipse (Davol) – Balloon Inflation (2023)

Spicer Ultimate Dana 60 Axle (Spicer) – Suspension Bracket (2023)

Silver Lake (East to West) – Label Issue (2023)

Forest River Columbus (Forest River) – Tire Riser (2022)

Xpert Xpress Strep A (Cepheid) – Pipette Failure (2023)

Xpert Xpress Strep A (Cepheid) - Sample Volume Failure (2023)

Aligned Medical Solutions Minor Hand Pack (Windstone Medical) - Handle Cover Risk (2023)

Nova Bus LFS (Nova Bus) – Battery Coolant (2023)

Spine Pack (Windstone) – Light Handle Detachment (2023)

Aligned Medical Solutions Hand Pack (Windstone Medical) - Handle Cover Risk (2023)

Alinity i Anti-TPO Reagent Kit (Abbott) - Fill Volume Error (2023)

Forest River Wildwood (Forest River) - Brake Wiring Problem (2023)

Aspira Pleural Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Valve Repair Kit (Merit Medical) - Valve Malfunction (2023)

Aspira Peritoneal Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Aspira Drainage Catheter Tray (Merit Medical) - Valve Malfunction (2023)

Coachmen Nova (Coachmen) - Fuel System Issue (2023)

Shred-Tech MDS-4-33 (Shred-Tech) - Paper Accumulation Risk (2023)