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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...

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