User Responsibility; Storage And Disposal - 3M E. coli O157 Gebrauchsanweisungen

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User Responsibility

Users are responsible for familiarizing themselves with product instructions and information. Visit our website at
www.3M.com/foodsafety, or contact your local 3M representative or distributor for more information.
When selecting a test method, it is important to recognize that external factors such as sampling methods, testing
protocols, sample preparation, handling, and laboratory technique may influence results.
It is the user's responsibility in selecting any test method or product to evaluate a sufficient number of samples with the
appropriate matrices and microbial challenges to satisfy the user that the chosen test method meets the user's criteria.
It is also the user's responsibility to determine that any test methods and results meet its customers' and suppliers'
requirements.
As with any test method, results obtained from use of any 3M Food Safety product do not constitute a guarantee of the
quality of the matrices or processes tested.
To help customers evaluate the method for various food matrices, 3M has developed the 3M™ Molecular Detection
Matrix Control kit. When needed, use the Matrix Control (MC) to determine if the matrix has the ability to impact the 3M
Molecular Detection Assay 2 - E. coli O157 (including H7) results. Test several samples, representative of the matrix, i.e.
samples obtained from different origin, during any validation period when adopting the 3M method or when testing new or
unknown matrices or matrices that have undergone raw material or process changes.
A matrix can be defined as a type of product with intrinsic properties such as composition and process. Differences
between matrices may be as simple as the effects caused by differences in their processing or presentation for example,
raw versus pasteurized; fresh versus dried, etc.
Limitation of Warranties / Limited Remedy
EXCEPT AS EXPRESSLY STATED IN A LIMITED WARRANTY SECTION OF INDIVIDUAL PRODUCT PACKAGING, 3M
DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, ANY WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE. If any 3M Food Safety Product is defective, 3M or its
authorized distributor will, at its option, replace or refund the purchase price of the product. These are your exclusive
remedies. You must promptly notify 3M within sixty days of discovery of any suspected defects in a product and return
it to 3M. Please call Customer Service (1-800-328-1671 in the U.S.) or your official 3M Food Safety representative for a
Returned Goods Authorization.
Limitation of 3M Liability
3M WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGES, WHETHER DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS. In no event shall 3M's liability under
any legal theory exceed the purchase price of the product alleged to be defective.

Storage and Disposal

Store the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) at 2-8°C. Do not freeze. Keep kit away from light
during storage. After opening the kit, check that the foil pouch is undamaged. If the pouch is damaged, do not use. After
opening, unused reagent tubes should always be stored in the re-sealable pouch with the desiccant inside to maintain
stability of the lyophilized reagents. Store resealed pouches at 2-8°C for no longer than 60 days.
Do not use 3M Molecular Detection Assay 2 - E. coli O157 (including H7) past the expiration date. Expiration date and
lot number are noted on the outside label of the box. After use, the enrichment medium and the 3M Molecular Detection
Assay 2 - E. coli O157 (including H7) tubes can potentially contain pathogenic materials. When testing is complete, follow
current industry standards for the disposal of contaminated waste. Consult the Safety Data Sheet for additional information
and local regulations for disposal.
Instructions for Use
Follow all instructions carefully. Failure to do so may lead to inaccurate results.
The user should complete the 3M Molecular Detection System operator qualification training, as described in the
"Installation Qualification (IQ) / Operational Qualification (OQ) Protocols and Instructions for 3M Molecular Detection
System" document .
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Periodically decontaminate laboratory benches and equipment (pipettes, cap/decap tools, etc.) with a 1- 5% (v:v in water)
household bleach solution or DNA removal solution.
See Section "Specific Instructions for validated methods" for specific requirements:
Table 3 for enrichment protocols according to AOAC® Official Method of Analysis 2017.01
SM
Table 4 for enrichment protocols according to NF Validation certificate 3M 01/18-05/17
Sample Enrichment
Tables 2, 3 or 4 present guidance for enrichment protocols for food. It is the user's responsibility to validate alternate
sampling protocols or dilution ratios to ensure this test method meets the user's criteria.
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