Deceptive Meridian Temperature Tablets Endanger Public Safety

By John Honovich, Published Oct 21, 2020, 01:22pm EDT

IPVM's testing of and investigation into Meridian Kiosk's temperature screening devices show that Meridian has deceived the public endangering safety. This 1-minute video explains:

Meridian Sales

Meridian has sold these devices to school districts in at least 9 states as well as the US Air Force and the US Veteran's Administration (re-sellers include CDW and Staples), according to a government records review IPVM has done, highlighted below:

IPVM Image

'Not A Medical Device'

We bought the device from Meridian and the unit itself plainly declares that "This is not a medical device" as the excerpt below shows:

IPVM Image

It Is A Medical Device, Per The FDA

However, it is a medical device, per the FDA. All devices that screen for elevated human temperatures are considered medical devices by the FDA.

Get Notified of Video Surveillance Breaking News
Get Notified of Video Surveillance Breaking News

Country of Origin Not Disclosed

Secondly, the unit has no country of origin marked on the unit. However, US law requires devices to be marked with their country of origin, see 19 U.S.C. § 1304 - U.S. Code Title 19. Customs Duties § 1304 | FindLaw.

The closest Meridian gets to addressing where this is made is their FAQ where they avoid answering their own question of where it was made, saying:

Where is the Personnel Management Kiosk manufactured?

We have parts from USA, China, and Germany that make up the Personnel Management Kiosk, with all final assembly, testing, software setup and shipping from Aberdeen North Carolina USA.

Verified Made in China

However, we verified that the unit was made in China by buying the Meridian unit (for $2,600) and the same fundamental unit from China ($600), as the hardware side by side below shows:

IPVM Image

Moreover, we examined the software and UI for both models which matched with only minor cosmetic differences, as shown below:

IPVM Image

Meridian separately sells MzeroManagement, an add-on management software.

Performance / Accuracy Problems

Most importantly, we tested the Meridian device we bought from them and found it had fundamental accuracy problems detecting elevated temperatures:

IPVM Image

The Meridian, much like the China tablets we have tested, normalized temperature readouts, which has the positive impact of making people think that they are safe but the negative public health risk of missing people who are febrile.

For more, see IPVM's temperature tablet shootout.

Meridian Responds

We previewed our concerns with Meridian. Meridian sent a 2-page response to IPVM.

On the China sourcing, Meridian first said they could provide evidence to disprove us:

None of our components are sourced through BEMS or other resellers, thus we are not a relabel of the BEMS unit. We can provide further evidence to this fact if needed.

However, when we asked for that evidence, they declined to provide. The evidence from our testing clearly shows its China sourcing.

On the made in US element, Meridian said it does not represent that it is "made in the USA" but that the "full kiosk is manufactured and assembled in the USA":

Meridian does not represent that our product, as a whole, is “made in the USA”. Our product contains components sourced from the US, China and Germany, as made clear in our documentation. The head unit, made in China, and the Thermopile Sensor, made in Germany, are components of the full kiosk which is manufactured and assembled in the US.

The 'head unit', as they call it, is the fundamental device itself. It is the core hardware and the software that runs the system, the stand they attach it to is ancillary, at best, and not transformative.

On the medical device element, Meridian told IPVM that they are "currently pursuing 510(k) certification". However, an FDA 510(k) is only needed by medical devices yet Meridian's device is labeled 'not a medical device'. We noted this discrepancy to Meridian but they declined to comment further.

Furthermore, Meridian provided us an Opinion Letter RE: Regulatory Status of Kiosk with Thermal Camera, with their attorney noting that the FDA considers such devices "regulated as medical devices":

In this enforcement policy, FDA states that telethermographic systems intended for a “medical purpose,” are regulated as medical devices. FDA construes “medical purpose” broadly, to include body temperature assessment, even when not in a healthcare environment.

We agree with this attorney. The FDA does consider their device to be a medical device, contrary to Meridian's labeling on their product.

Simplistic Test Process Disclosed

Notably, the letter also gives insight into the simplistic testing process Meridian claims, saying:

Laboratory temperature accuracy was assessed over a temperature range of 34- 39°C, and the measurement uncertainty was confirmed to be less than or equal to ±0.5°C. The system uses the NightinGale blackbody temperature reference source, which is set at 12 inches from the sensor face.

This testing process is significantly easier to achieve than what Meridian actually markets, much closer and much larger than the area of a human elevated temperature. For example, the subject distance Meridian recommends is 75% farther away, at 20 inches versus the 12 inches this test specifies. Moreover, the blackbody they used has a "3” Square Emitting Aperture", which is much larger and more uniform than the area of a face that typically shows the subject's maximum temperature. This is, of course, not the fault of the blackbody but the test process used.

While the letter provides no further details on the test and the attorney author did not respond to our request for comment, this 'test' reveals a process that does not properly represent their use case and the flaws risked in doing so.

Risk To Public Safety

As IPVM has reported throughout 2020, this fits an ongoing trend of significant amounts of money being spent on devices that may not help public safety. Worse, the false sense of security these devices contribute to could make things even worse, while deceptive sellers like Meridian profit.

2 reports cite this report:

Secretary of Veterans Affairs Responds To IPVM Investigation on Nov 13, 2020
Veterans Affairs Secretary, Robert Wilkie, caused more concern about the VA’s...
VA Fever Screening Purchases Endanger Veterans' Lives on Nov 09, 2020
The US Department of Veterans Affairs has spent millions of dollars on a...

Comments (6)

Only IPVM Members may comment. Login or Join.

Not sure where to put this but figure here is good enough.

Bravo to IPVM team. The speed at which content is coming out lately has been tremendous, just today 3 separate reviews of product offerings in addition to the 4 market focused articles yesterday. It is almost hard to keep up anymore where in the past I would only see one or two a week it felt like.

986 Labs is also marketing the same tablet/kiosk for what looks to be $2995. Most of these style devices that I have seen are mounted/used in such a way as to be totally useless and not in compliance with CDC/ISO guidelines as well.

"Performance / Accuracy Problems

Most importantly, we tested the Meridian device we bought from them and found it had fundamental accuracy problems detecting elevated temperatures:"

Can you display all the readings taken?

Ben, thanks! Each tablet is tested hundreds of times with various subjects, with forehead temperature measurements ranging from cooled, "normal", and heated. The video below demonstrates how IPVM conducts testing (same method for both cameras and tablets) versus how rigged devices throw up a hot water bottle, have the device measure it, and call it a day, saying the kiosk "works".

This is getting ridiculous. When is the FDA going to step up and say enough is enough with these get-rich-quick scam artists and their dangerous, illegal devices? No wonder the USA has the highest number of COVID cases in the world.

I am fairly certain the hospital complex where my family Dr resides is using one of these devices. I explained to the lady how they were using it wrong and that fact these types of devices aren't very accurate. You walk in and the unit is only about 15' from the door and you are asked to look into the device as soon as you walk up to it. Not sure who all is asked to get there temp reading though as not everyone was getting checked. May just be for visitors or depending on which part of the complex you are going.

I also asked if they ever double checked readings with a manual thermometer. She said they had not checked anyone manually and she would pass along what I told her to the supervisor. Guaranteed that fell to deaf ears.

So sad that a hospital is too lazy to actually test people manually to get an accurate reading.

Loading Related Reports