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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.
WARNING:
Indicates a hazardous situation, which, if not avoided, could result in
death or serious injury and/or property damage.
CAUTION:
Indicates a hazardous situation, which, if not avoided, could result in
minor or moderate injury and/or property damage.
NOTICE:
Indicates a potentially hazardous situation which, if not avoided, could
result in property damage.
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/IEC 17025
(4)
, or ISO 7218
(5).
The user shouldcomplete 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
(6)
.
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.