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[IP] Something sent to our Endo team
>Attention Endocrine Society members:
>Roche Diagnostics Corporation has identified a test strip vial defect that
>will cause erroneously low or high blood glucose readings. The potentially
>affected test strips are:
> * Accu-Chek Comfort Curve test strips, part numbers 2030420, 2030365,
> 2030373, 2030381, 3000133, 3000141 and
> * Accu-Chek Advantage test strips, part numbers 336, 553, 787 and 966.
>These are most of the currently available lots. Roche Diagnostics is
>encouraging consumers to inspect every vial for this defect prior to each
>use. According to the company, the defect appears as an obvious crack in
>the bottom of the vial. A crack may develop after the vial has been opened
>and quality control testing performed. Since the test strip results are
>inaccurate when exposed to moisture, a crack in the vial will impact the
>reliability of subsequent tests.
>Roche is asking doctors to advise patients and laboratories of the following:
> * Always follow quality control instructions provided in the product
> labeling as well as those established at your facility.
> * Inspect every vial for this defect before each use. Do not use test
> strips if a crack is observed.
> * If you do not observe a crack in the vial and the blood sugar result
> seems unusually high, low or inconsistent with previous results or
> glucose trends and does not reflect the clinical picture, run a quality
> control check with your glucose control solutions and a new test strip.
> * If the control result is within the acceptable range, review proper
> testing procedure and repeat the blood glucose test with a new test strip.
> * If the control result is not within the acceptable range, contact
> the Accu-Chek Costumer CareSM Center at 1-800-858-8072.
>If you observe a cracked vial, please call 1-800-440-3638 to arrange for a
>replacement product. Your patients may call 1-800-858-8072 to arrange for
>The Endocrine Society will continue to monitor this situation and will
>keep you informed of any new developments. Thank you.
ICQ # 27217438
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