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Medical device recalls

Medical device recalls from FDA, newest first.
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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

1 recall

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

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