All Recalls

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Due to incomplete seals in the pouch which provide the sterile barrier.

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Potential for contamination with cotton fibers.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Product lacks 510(k) clearance.