Diagnostic Equipment

A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1)

When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.

Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.

The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Unit fails to power up, resulting in an equipment alarm

ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlock

Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.