All Recalls

Subpotent drug

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Firm has received reports of patient burns in surgical procedures where device was used.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range