Surestep Blood Glucose Meter: Overview

Modified on 2009/10/14 21:34 by admin
In 1998, Johnson & Johnson announced a recall of its Surestep Blood Glucose Meters manufactured before 1997. LifeScan, a Johnson & Johnson company, produces the Surestep meter. The company instituted the recall because the instrument may produce an error message when the patient's blood glucose is very high. If a high blood glucose level goes untreated, it can result in very serious health consequences, including death. Only meters produced before 1997 are subject to the recall. According to the Food and Drug Administration (FDA), LifeScan was aware of Surestep's defect as early as 1993. When the company applied for FDA approval of the device in 1994 it did not reveal the error message problem to the agency.

In 1997, company whistleblowers came forward to notify authorities of the problems with the meters. A three-year investigation of LifeScan followed. In December 2000, LifeScan pleaded guilty to misdemeanor charges and agreed to pay $60 million in criminal and civil fines. The company admitted that the reports it filed contained false or misleading information regarding the Surestep system.

See your doctor if you use one of these defective Surestep Blood Glucose Meters. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Medical Devices & Implants
  2. Polyuria: Overview
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