Johnson & Johnson Lifescan
This article was originally published in The Gray Sheet
Executive Summary
J&J division is sending users of SureStep over-the-counter blood glucose meters manufactured prior to August 1997 a warning sticker that reads: "Notice, Er 1 [readings] may mean a very high blood glucose. Check color chart on strip vial." The firm is instructing users to affix the sticker to existing SureStep systems (including those with serial numbers beginning L6000 through L7205) until a replacement meter is obtained free-of-charge by calling a toll free number. A letter describing the situation and including a SureStep reference guide also is being sent. The move is part of the firm's voluntary recall effort for a subset of SureStep devices, and comes in the midst of an FDA/California attorney general probe investigating, in part, whether the device gives an "Er 1" (Error 1) message if a patient's blood glucose level is 500 mg/dL or greater ("The Gray Sheet" April 13, p. 32). Users who obtain an Er 1 message should "compare the blue color dot on the test strip with the color chart on the back of the test strip bottle," J&J says in a June 4 release. "If the dot on the strip is as dark or darker than the darkest oval on the bottle's color chart, they likely have a very high blood glucose," and the user should immediately contact a health care professional...
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.