All Recalls

Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Patient support table floor plate may be incorrectly installed.

Complaints have been received with allegations of Incorrect Needle Curvature.

The failure to detect the partial obstruction in a 2.5mm sensor.

The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Patient support table floor plate may be incorrectly installed.

Patient support table floor plate may be incorrectly installed.

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Patient support table floor plate may be incorrectly installed.