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IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)

The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

Moderate

FDASep 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Precice Max Femur Implant (NuVasive) – Design and Manufacturing Issue (2024)

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Moderate

FDASep 30, 2024FL, NV• NuVasive Specialized Orthopedics, Inc.

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IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)

Precice Max Femur Implant (NuVasive) – Design and Manufacturing Issue (2024)

Westby Cheese Curds (Westby Cooperative Creamery) – E. Coli Risk (2024)

Westby Pepper Cheese Curds (Westby Cooperative Creamery) – E. Coli Risk (2024)

King Harvest Spinach Hummus (Pacific Coast Fresh) – Plastic Fragment Risk (2024)

Flex Extenders (Westmed) – Connector Connection Force Problem (2024)

AVOXimeter 1000E (Accriva) – Calibration Value Inaccuracy (2024)

Lunds & Byerlys Lone Star Dip (Lund Food Holdings) – Mold Contamination (2024)

King LTSD Size 2 (King Systems) – Pediatric Use Risk (2024)

King LTSD Size 1 (King Systems) – Pediatric Use Risk (2024)

King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Great Value Cherry Mixed Fruit (Walmart) – Undeclared Food Coloring (2024)

Duraform Dural Graft Implant (Integra) – Endotoxin Levels (2024)

Horizon Organic Heavy Whipping Cream (Horizon) – Premature Spoilage (2024)

King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)

Great Value Diced Fruit Variety Pack (Walmart) – Undeclared Food Coloring (2024)

Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)

Coated VICRYL Suture (Ethicon) – Needle Pull-Off (2024)

Monoject Insulin Syringe (Cardinal Health) – Incompatibility Risk (2024)