LIFESCAN, INC.
a Johnson & Johnson Company

Press Contact:
Jeffrey J. Leebaw
(732) 524-3350

FOR IMMEDIATE RELEASE

Milpitas, CA (June 4, 1998) - SureStep Consumer Meters made before August 1997 may give an "Er 1" (Error 1) message if a patient's blood glucose (sugar) is very high - 500 mg/dL or greater. Failure to recognize a seriously high blood glucose level could cause serious health consequences, including hospitalization and death.

LifeScan is asking all patients who use the SureStep Consumer Blood Glucose Meter made before August 1997 to call the company's special 24-hour customer service line (1-800-951-7226) for important information about the product and how to get a free replacement meter.

Patients should continue to test their blood glucose. If they get an "Er 1" message with the SureStep Consumer Meter, patients should be aware that they may have very high blood glucose. Therefore, it is important for them to compare the blue color dot on the test strip with the color chart on the test strip bottle. 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. They should then call their healthcare professional immediately.

To identify a SureStep Meter manufactured before August 1997, patients should first check to see if their meter is a SureStep Meter and then look for the serial number on the back of the meter. Units that have serial numbers beginning with L6000 XX XXXXX through L7205 XX XXXXX are the units that will be replaced. Units with serial numbers L7206 XX XXXXX and higher are not being replaced.

All users of SureStep Meters with the serial numbers identified above are asked to call LifeScan's special 24-hour customer service line at 1-800-951-7226. SureStep Meter users with questions about this replacement program are also encouraged to call. LifeScan will provide users with new instructions, and will also arrange to replace all affected meters free of charte. Until a replacement meter can be provided, LifdScan will be sending a warning sticker about the "Er 1" message to be attached to the affected meter. The warning sitcker says "NOTICE Er1 may mean very high blood glucose. Check color chart on strip vial."

LifeScan has informed the United States Food and Drug Administration (FDA) of the voluntary actions it is taking and the Agency has categorized these actions as a recall.

LifeScan has taken a number of steps to get this information about the "Er 1" message out to patients, physicians and pharmacists. Beginning late last year the company started packaging a SureStep Owner's Booklet addendum in every retail box of consumer SureStep Test Strips. The addendum advises patients who receive an "Error 1" message to be sure to consult the backup color chart system. LifeScan also recently sent patients a letter about the additional meaning of the "Error 1" message and a reminder to use the backup color chart system.

LifeScan revised the software for all SureStep Consumer meters manufactured beginning in August 1997. The company believes this revision virtually eliminates the chance of receiving an "Er 1" message with glucose levels in excess of 500mg/dL.

It is very important for patients to always follow labeling and instructions when using any device related to their personal health. Therefore, LifeScan is sending SureStep customers a letter describing the situation and including a SureStep "Quick Reference Guide" to reinforce the instructions for use of the meter.

Patients have come to rely on LifeScan for accurate monitoring systems to help them manage their diabetes. LifeScan, a Johnson & Johnson company, greatly values the trust and confidence that people with diabetes have shown in its productrs over the years and intends to continue meeting the needs of its customers.

# # #

***This notice affects only the consumer SureStep Blood Glucose Meters, not the SureStep Pro Hospital System or any other LifeScan Products.***

---