For those who got the free Bayer Ascensia Contour Glucose, for use on
our ferrets and ourselves, please check the S/N to make sure yours is
not one of the recalled.
Class 1 Recall: Bayer Ascensia(r) Contour(r) Blood Glucose Monitoring
System!
Date Recall InitiatedJune 6, 2007
Product: Bayer Ascensia(r) Contour(r) Blood Glucose Monitoring System,
Product 7152A.
The system consists of a meter, test strips contained in a dry
(desiccated) bottle, a bottle of test solution, a lancing device and
lancets and instructions for use.
Serial numbers include: 1475139, 1688643, 1841620, 1852071, 2064303,
2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260,
2280056, 2317037, and 2319010.
These meters were distributed from March 23, 2007 through May 31, 2007.
Use: Diabetes patients use blood glucose meters to measure the
amount of glucose in their blood, and as an aid in monitoring the
effectiveness of diabetes management in the home and/or by healthcare
professionals in healthcare facilities.
Recalling Firm:
Bayer Healthcare LLC
430 S. Beiger St.
Mishawaka, IN 46544-3207
Reason for Recall: The meters reported the wrong units of measure for
Canadian users. Instead of mmol/L, which is the appropriate measurement
for Canadian users, the meters were reporting mg/dL. Contractors
change the meters to the appropriate units of measure before they
are packaged. The contractor shipped 32 meters to Canada that were
distributed with the wrong unit of measure (mg/dL - units used in the
U.S.) instead of mmol/L.
Consumers may misinterpret the blood glucose results displayed by the
meter and adjust treatment according to the misinterpreted result.
They may overestimate the glucose value by 18 times what they actually
are and over treat themselves. Consumers may have a reaction of
hypoglycemia but its symptoms may prevent them from self- treatment.
Also, some consumers may lack the classic signs of hypoglycemia to
receive proper treatment.
Public Contact: Consumers may call Bayer Healthcare at 1-574-256-3441.
FDA District: Detroit
FDA Comment: The firm began calling its Canadian customers on or about
June 6, 2007 to inform them of the problem, to tell them that a meter
with the correct measurement units will be sent to them, and to request
that they return the meter currently in their possession. Canadian
health officials were notified via email on June 12, 2007 and
reportedly informed Bayer that a press release was not necessary due
to the limited number of units involved.
Bayer determined that only 16 of the meters had been further
distributed beyond the distribution facility in Canada, although 32
correct meters had been shipped to Canada. As of June 11, 2007, the
16 distributed were accounted for as follows: 2 were returned by
customers, 7 were located in Canada at distributor or retailer
warehouses, 2 were located with customers using the warranty database
and the remaining 5 are presumed sold but have not been located.
On June 11, 2007, the contractor added a verification check to its
software. Bayer is verifying that all stock on hand have been
configured properly for units that were supposed to have been
reconfigured before the controls went into affect. Class 1 recalls
are the most serious type of recall and involve situations in which
there is a reasonable probability that use of the product will cause
serious injury or death.
Health care professionals and consumers may report adverse reactions or
quality problems experienced with the use of this product to the FDA's
MedWatch Adverse Event Reporting program either online, by regular mail
or by FAX.
[Posted in FML 5700]
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