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FDA recalls blood sugar monitors

NEW YORK, Jul 28 (Reuters) -- All SureStep home blood glucose meters
manufactured prior to August 1997 have been recalled by the
manufacturer, the US Food and Drug Administration (FDA) announced on
Tuesday.

These SureStep blood glucose meters, manufactured by LifeScan Inc., may
give an error message, "Er 1," instead of a "HI" reading when a person
has very high blood sugar levels. The faulty reading was classified by
the FDA as a "situation in which there is a reasonable probability that
the use of the product will cause serious adverse health consequences or
death."

At least two people who received an "Er 1" message on their SureStep
meters have died, reports the FDA. In both of these cases, the diabetics
had very high blood glucose levels, but delayed seeking medical care.

In early June, LifeScan Inc, the Milpitas, California-based subsidiary
of Johnson and Johnson, announced a plan to replace SureStep home
glucose meters because of the faulty readings. But according to a
statement issued Tuesday, the FDA "is concerned that some diabetics,
wholesalers, and distributors who purchased these meters may not realize
this product replacement is for a potentially serious malfunction." More
information is available from the company's 24-hour customer service
line at 1-800-951-7226.

Please let all diabetic family and friends know,
Gail Vass, R.N.