Diagnostic Equipment

Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).

Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).

GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator.

The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.

May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Intermittent potential for shorter than expected clot times.

Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.

Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

Recalled products do not have FDA approval for sale in the United States.

Medical device non-conformance to electrical safety standard (IEC 60601-1).

A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.