AOAC-RI ERP Micro June 2016

OMAMAN-29 B/ IFU OMA ERP June 2016 ERP Use Only

SAFETY The user should read, understand and follow all safety information in the instructions for the 3M Molecular Detection System and the 3M Molecular Detection Assay 2 - Listeria. Retain the safety instructions for future reference.

Indicates a hazardous situation, which, if not avoided, could result in death or serious injury and/or property damage.

WARNING:

Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury and/or property damage.

CAUTION:

Indicates a potentially hazardous situation which, if not avoided, could result in property damage.

NOTICE:

WARNING Do not use the 3M Molecular Detection Assay 2 - Listeria in the diagnosis of conditions in humans or animals. The 3M Molecular Detection Assay 2 - Listeria method may generate Listeria monocytogenes to levels sufficient to cause stillbirths and fatalities in pregnant women and the immunocompromised, if exposed.

The user must train its personnel in current proper testing techniques: for example, Good Laboratory Practices, ISO/IEC17025 (4) , or ISO 7218 (5).

AOAC Research Institute Expert Review Panel Use Only

To reduce the risks associated with a false-negative result leading to the release of contaminated product: • Follow the protocol and perform the tests exactly as stated in the product instructions. • Store the 3M Molecular Detection Assay 2 - Listeria as indicated on the package and in the product instructions. • Always use the 3M Molecular Detection Assay 2 - Listeria by the expiration date. • Use the 3M Molecular Detection Assay 2 - Listeria for food and environmental samples that have been validated internally or by a third party. • Use the 3M Molecular Detection Assay 2 - Listeria only for surfaces, sanitizers, protocols and bacterial strains thathave been validated internally or by a third party. • For an environmental sample containing Neutralizing Buffer with aryl sulfonate complex, perform a 1:2 dilution before testing (1 part sample into 1 part sterile enrichment broth). Another option is to

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