Abbott Laboratories (ABT) shares closed Friday's session at $110.83, marking a 1.6% gain. Despite the advance, the stock continues to trade significantly below its 52-week peak of $141.23, representing a discount of over 21%. Trading volume for the day was elevated at 9.9 million shares.
FDA Escalates Recall for Diabetes Sensors
Investor focus is shifting to regulatory developments concerning Abbott's diabetes segment. The U.S. Food and Drug Administration has escalated a Class I recall—its most serious designation—for specific lots of FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitoring sensors. The agency warns that the devices may report inaccurately low glucose readings, potentially leading to dangerous treatment errors. Abbott has reported 860 serious injuries and seven fatalities linked to the issue to the regulator.
Insider Purchase and Cardiac Device Data
Amid the regulatory news, Abbott director Daniel J. Starks acquired 10,000 company shares on February 4 in open market transactions valued at approximately $1.09 million. Separately, the company presented new clinical data at the AF Symposium in Boston. Its Volt pulsed field ablation system demonstrated an 84.2% freedom-from-recurrence rate at 12 months for paroxysmal atrial fibrillation cases, and its TactiFlex Duo device showed an 81% success rate at six months.
Analysts note that while the FDA's warning letter adds uncertainty for investors, Abbott has indicated its Libre marketing and distribution remain unaffected. The company also reaffirmed plans to launch a dual glucose/ketone sensor later this year.
As markets prepare to reopen, attention will center on potential further FDA communications and any updates from Abbott regarding sensor replacements. The interplay between regulatory headwinds for its diabetes business and promising data from its cardiac ablation portfolio is likely to influence near-term stock movement.
