Figures revolving around recalls fluctuate from year to year and even quarter to quarter. In early 2022, however, an uptick in medical device recalls tied to COVID-19 rapid test kits made waves. Below we’ll first discuss the reasons and the figures behind it. Then we’ll lay out what you can glean from it moving forward to better protect your organization.

Why So Many Medical Device Recalls For Rapid Test Kits & How Were They Distributed in the First Place?

Why were so many medical device issues issued for COVID-19 rapid test kits from so many different brands? How did so many unsafe variations leak out into the market? Here’s some background information that can give you context as well as figures to put it into perspective.

Background

During the height of the pandemic, new COVID-19 variants were developing and threatening public safety. Many organizations worked to combat the spread of COVID-19 by requiring negative results to go to work, travel, or attend events. Demand for antigen tests was massive. To keep up with the demand for testing resources, many manufacturers wanted to get their products to market and capitalize on this demand.

With the flood of rapid test kits hitting the market, the FDA likely hit a wall. Its available resources only allow it to inspect and monitor so many products at a time. They’re even less able to conduct consistent post-market surveillance or ensure that manufacturers are. As a result of these manufacturer-side and FDA-side elements clashing, products not approved for consumer use stay on the market causing confusion and harm before the FDA could issue any medical device recalls.

According to a report by Sedgewick, highly contagious variants have kept the demand for at-home tests high. And that to capitalize on this, some companies will try to get their products to market quickly by cutting corners and distributing them without FDA approval.

Figures On The Medical Device Recalls Issued

Authors of the same report stated that either the FDA or manufacturer issued a total of 9 medical device recalls for unapproved or unsafe COVID-19 rapid tests in the second quarter of 2022. This affected a total of approximately 982,483 units.

Here are just some of last year’s major recalls regarding COVID-19 rapid test kits:

• North American Diagnostics – 122,175 total units affected
• E25Bio – 73,300 total units affected
• Woodside Acquisitions – 51,240 total units affected

According to an article by Health.com, other kits recalled include:

• SD Biosensor Inc’s Standard Q COVID-19 AG Home Test
• Empowered Diagnostics’ CovClear COVID-19 Rapid Antigen Test & ImmunoPass COVID-19 Neutralizing Antibody Rapid Test
• ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test
• Ellume COVID-19 Home Test

These all ranged from voluntary manufacturer recalls to class I recalls, which is the FDA’s most severe label for medical device recalls. The FDA labels recalls as class I when the product in question can cause severe injuries or death. 

These devices were recalled for a variety of reasons including false positives, illegal importation, manufacturing issues, and circumventing FDA approval for distribution or use.

The Damage Caused & How To Avoid It During Future Public Health Crises

COVID-19, as many lives as it has claimed, was not the first pandemic and unfortunately will not be the last. While we certainly can’t prevent public health crises from forming, we can learn from each one. The insights we gain can help us stay alert and mitigate the risk from our end as much as possible. This case in particular is a shining example that while the FDA is certainly a quality assurance line of defense, it is nowhere near infallible. Expecting it to catch any and all manufacturer defects, or assuming that all medical devices will go through their approval process is a gamble.

Even products that pass the FDA regulatory process may have done so through a 501(k) loophole https://jamanetwork.com/journals/jama/article-abstract/2800187  or otherwise have unsafe features that fly under the radar. The FDA may issue a medical device recall, but by the time it identifies and takes action on a problem, the product in question may have already caused unnecessary damage.

Don’t wait on recalls to ensure your organization’s safety. Take safety into your own hands with Device Events. Our software makes finding medical device recalls and even reports in the FDA’s database easily accessible and readable. Transforming your search experience translates to exponential efficiency increases in your data-gathering and decision-making process. This in turn helps you take the preventative steps necessary to protect your organization and any patients that depend on it. Contact us today to see how we can help your organization get ahead of the next wave of unsafe medical devices.