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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate risk, FDA, Device defect

1 recall

Meridian Bioscience Revogene C. Difficile Assay

The Revogene C. difficile assay may show a decline in performance over time, leading to false-negative results.

Moderate risk, FDA, Device defect

2 recalls

Roche Diagnostics Elecsys Anti-TSHR Immunoassay

The Elecsys Anti-TSHR immunoassay results vary by instrument platform and calibrator lot, which may lead to delayed or incorrect diagnosis.

Moderate risk, FDA, Device defect

Applied Medical Kii Low Profile Bladed Dual Pack

Kii Low Profile, Bladed Dual Pack has a potential for extended blade obturator length after assembly.

Moderate risk, FDA, Device defect

1 recall

Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

A manufacturing issue may cause carbon build up in the sensor, leading to incorrect low glucose results.

High risk, FDA, Device defect