Lifescan May Be Misleading Customers About SureStep Recall, FDA Says
This article was originally published in The Gray Sheet
Purchasers of Lifescan's SureStep home glucose monitors may be "misled" by the firm's recall, which the Johnson & Johnson subsidiary "has characterized...as a product replacement program," FDA cautioned in a July 28 press release following up the company's June 4 Class I recall.
You may also be interested in...
Johnson & Johnson subsidiary LifeScan will remain on probation for a three-year period, during which FDA and the U.S. Probation Office will oversee the firm's documentation of medical device reporting (MDR) complaints.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.