Introduction
11
Introduction
The Accutrend Plus instrument
The Accutrend Plus instrument is used for quantitative measurement of 2 blood parameters: glucose and
cholesterol. The instrument is suitable for professional use as well as for self-testing.
If you have any questions which are not answered by this manual, call the ACCU-CHEK Customer Care Service
Center 24 hours a day, 365 days a year at 1-800-440-3638
CLIA Waived
This is a CLIA Waived test system. A Certificate of CLIA Waiver (or higher) is required to perform the test. Information on obtaining CLIA certificates
can be found at www.cms.hhs.gov/clia.
Before testing, refer to the appropriate package insert for more complete information. Laboratories with a certificate of waiver must follow the
manufacturer’s instructions for performing the test. 42 CFR 493.15(e)(1).
Any modifications and/or failure to follow test system instructions, including those for limitations/intended use and performance of QC testing as a
failure alert mechanism, results in use that is considered high complexity and subject to all applicable CLIA requirements.
All applicable state and local laws must be met.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Adverse
Event Reporting program online (at www.fda.gov/MedWatch/report.htm), by phone (1-800-FDA-1088), or by returning the postage-paid FDA
form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm) by mail to (MedWatch, 5600 Fishers Lane, Rockville,
MD 20852-9787) or fax (1-800-FDA-1078).
If there are any problems with the Accutrend Plus meter, notify CMS at http://www.cms.hhs.gov/clia/ro-map.asp
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