Medical Devices Recalls

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Unapproved design changes to the products outside of the 510(k) clearance.

Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Unapproved design changes to the products outside of the 510(k) clearance.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Unapproved design changes to the products outside of the 510(k) clearance.

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.