Diagnostic Equipment

Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.

Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received five (5) complaints related to this issue with no serious injuries reported.

A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.

There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.

In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours, which may lead to delays in carrying out the subsequent analysis tests.

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support