All Recalls

No 510k for the product to be used in a natural or surgical opening to the body

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.

No 510k for the product to be used in a natural or surgical opening to the body

No 510k for the product to be used in a natural or surgical opening to the body

No 510k for the product to be used in a natural or surgical opening to the body

Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

No 510k for the product to be used in a natural or surgical opening to the body

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

No 510k for the product to be used in a natural or surgical opening to the body

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

No 510k for the product to be used in a natural or surgical opening to the body

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

No 510k for the product to be used in a natural or surgical opening to the body

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.