Devices & Diagnostics

FDA: warnings, recall for diagnostic equipment and two devices

The Food & Drug Administration issued warnings to Millipore Corp. and Cardiac Sciences Corp. and a Class I recall to Synthes USA. The FDA has concerns about one company’s diagnostic equipment, and malfunctioning defibrillators and vertebral implants from the other two companies.

The Food & Drug Administration issued a pair of warnings to Millipore Corp. and Cardiac Sciences Corp. and put out a Class I recall of Synthes USA’s Synex II vertebral implant.

Millipore warned on Swine Flu diagnostics claims

The FDA sent the Billerica, Mass.-based lab instruments maker a warning letter in September of last year about a promotional email the company sent out touting its influenza diagnostics.

According to an FDA missive dated Sept. 29, 2009, the agency said Millipore inappropriately promoted diagnostic equipment as being able to detect the H1N1 influenza virus, better known as the Swine Flu.

Agency officials wrote, “these products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus,” and ordered the company to amend its claims immediately in order to comply.

More recalls and warnings

The federal watchdog agency also said Cardiac Sciences received multiple complaints about malfunctions of its Powerheart and CardioValve automated external defibrillators.

The FDA said a malfunction of the Bothell, Wash.-based company’s device causes a warning light to act improperly. The device is supposed to run a self-test prior to administering a charge, but there have been complaints that the test is failing to detect malfunctions.

The agency said the malfunctions “could cause these AEDs to interrupt ECG analysis and thus prevent shock delivery, or fail to recognize that the pads have been placed. Malfunctions could also cause interference or background noise, which could prevent the device from accurately analyzing heart rhythm and delivering a shock,” according to the February issue of the FDA patient safety news.

About 300,000 defibrillators worldwide are affected by the malfunction.

The agency also issued a Class I recall, its highest-level callback, for the Synex II vertebral body replacement device made by West Chester, Pa.-based Synthes USA.

Synthes issued a recall for the Synex II in September after receiving six reports that the device collapsed without warning in patients six to 15 months after implantation. The malfunction caused patients to experience neural injury, increased pain and spinal compression fractures.

Physicians have been advised to stop using the implants and contact Synthes on how to return them. Patients already with the implants are advised to receive annual radiographic exams. A Class I recall is issued for devices the FDA believes could cause serious injury or death.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.