The company expanded a recall of its at-home Covid-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.
Medtronic is expanding a recall of two of its MiniMed 600 series insulin pumps after reports found several had broken retainer rings cracked, resulting in insulin doses that were too high or too low.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Apparently, the battery packs, used in its Coviden Oridon Capnostream 20 and Capnostream 20p, could cause "thermal damage." The devices are used to check respiratory status and keep tabs on breathing regularity.
Stryker Corp.’s OtisMed unit will pay $80 million in fines because the division distributed its knee replacement surgery devices without regulatory approval in 2009. Stryker said in a statement that the DOJ acknowledged that OtisMed’s criminal conduct “occurred prior to Stryker’s acquisition of OtisMed and without Stryker’s prior knowledge or acquiescence.” Bloomberg says: OtisMed will pay a fine of $34.4 million […]
Abbott (ABT) announced the medical device company will voluntarily recall 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the U.S. The company said in a statement the test strips may give low glucose readings when used with the FreeStyle Blood Glucose Meter, the FreeStyle Flash Blood Glucose Meter and the OmniPod Insulin Management […]
Atossa Genetics announced their Q3 earnings today, along with an update on their ForeCYTE Breast Health Test recall and plans for product launches and relaunches in 2014. Net loss for the quarter ended September 30, 2013, was $3.5 million, or $0.22 per share, compared with net loss of $1.1 million, or $0.10 per share, for […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Last week, we learned Q2’13 saw a five-period spike in medical device recalls. On LinkedIn a few weeks prior, Medical Devices Group leader Joe Hage posed this question to the group: “Are recalls preventable?” The discussion that follows is robust, smart and sometimes a bit heated. Here are five smart comments from a LinkedIn conversation […]
Last quarter was the highest in more than a year for recalls–up more than 30 percent from Q1, according to a report out from Stericycle ExpertRECALL. Q2’s 411 recalls only accounted for 9.2 million units, though–a 50 percent decrease from Q1. Of the 174 companies to issue recalls this quarter, nearly 40 percent issued more […]
For drug and device companies, a product recall is bad. Dealing with multiple recalls at the same time is worse. Trying to manage either scenario without a plan is nightmare territory. That’s what ExpertRECALL wanted to illustrate during a mock recall held last month in Indianapolis. The company devoted a half-day of the Bio/Pharmaceutical and […]
On Wednesday, St. Jude Medical CEO Dan Starks fielded a couple of questions related to its Durata ICD lead on its fourth-quarter earnings call, although there were none on a possible recall of the product, despite my expectations. The Durata ICD lead has been troubled by its association with a recalled, previous-generation ICD lead and […]
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(Reuters) - Johnson & Johnson is negotiating a potential $2 billion settlement with patients who received its recalled artificial hip implant, Bloomberg News reported on Friday, citing five people familiar with the matter. J&J has offered to pa...
Stryker issued an urgent medical device recall notice Tuesday noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance. The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are […]