en
TSH
07P4810
TSH Controls G72193R02
C7P480
Read Highlighted Changes: Revised December 2017.
NAME PREPARATION FOR USE
Alinity i TSH Controls (also referred to as TSH Ctrls) • This product is liquid ready-to-use.
INTENDED USE • This product may be used immediately after removal from 2 to
8°C storage.
The Alinity i TSH Controls are for the verification of the accuracy
and precision of the Alinity i analyzer when used for the quantitative • Prior to each use, mix by gentle inversion.
determination of human Thyroid Stimulating Hormone (TSH) in STORAGE
human serum and plasma. • Do not use past expiration date.
For additional information, refer to the Alinity i TSH reagent package Storage Maximum Additional Storage
insert and the Alinity ci-series Operations Manual. Temperature Storage Time Instructions
CONTENTS Unopened 2 to 8°C Until
, , and contain TSH (recombinant) expiration
prepared in TRIS buffer with protein (bovine) stabilizers. Preservative: date
sodium azide. Opened 2 to 8°C Until Store tightly capped.
The controls are at the following ranges and target concentrations: expiration Return to refrigerated
date storage after use.
TSH TSH
Control Quantity (μIU/mL) (μIU/mL) (mIU/L) (mIU/L)
INSTRUMENT PROCEDURE
1 x 8.0 mL 0.1 0.065 - 0.135 0.1 0.065 - 0.135 • To obtain the recommended volume requirements for the
controls, hold the bottle vertically, and dispense 4 drops of the
1 x 8.0 mL 6 3.9 - 8.1 6 3.9 - 8.1 low control, 4 drops of the medium control, and 4 drops of the
1 x 8.0 mL 30 19.5 - 40.5 30 19.5 - 40.5 high control into each sample cup in the assigned position.
• For instructions on ordering and loading controls on the
NOTE: The insert ranges for the controls are not lot specific instrument, refer to the Alinity ci-series Operations Manual,
and represent the total range of values which may be generated Section 5.
throughout the life of the product. It is recommended that each
laboratory establish its own means and acceptable ranges which INDICATIONS OF INSTABILITY OR DETERIORATION
should fall within the package insert ranges. Sources of variation that Instability or deterioration should be suspected if there are
can be expected include: precipitates, visible signs of leakage, turbidity, or if controls do
not meet the appropriate package insert and/or Alinity ci-series
• Calibration • Control lot • Reagent lot
Operations Manual criteria.
• Calibrator lot • Instrument
Note for number formatting:
STANDARDIZATION • A space is used as thousands separator (example: 10 000
The controls are manufactured by addition of Recombinant Human specimens).
TSH of known concentration to obtain a target concentration. This • A period is used to separate the integer part from the fractional
internally assigned concentration is established using calibration part of a number written in decimal form (example: 3.12%).
values referenced against WHO TSH 80/558.
PRECAUTIONS
•
• For In Vitro Diagnostic Use
•
Safety Precautions
The following warnings and precautions apply to: ,
, and
Contains sodium azide.
EUH032 Contact with acids liberates very toxic gas.
P501 Dispose of contents / container in
accordance with local regulations.
Safety Data Sheets are available at [Link] or
contact your local representative.
For a detailed discussion of safety precautions during system
operation, refer to the Alinity ci-series Operations Manual, Section 8.
1
Key to Symbols
ISO 15223 Symbols
Consult instructions for use
Manufacturer
Temperature limitation
Use by/Expiration date
In Vitro Diagnostic Medical
Device
Lot Number
List Number
Other Symbols
Control Number
Concentration
Contains Sodium Azide. Contact
with acids liberates very toxic
gas.
Control Low, Medium, High
(L,M,H)
Distributed in the USA by
Information needed for United
States of America only
Product of Ireland
Range
For use by or on the order of a
physician only (applicable to USA
classification only).
Alinity is a trademark of Abbott Laboratories in various jurisdictions.
All other trademarks are property of their respective owners.
Abbott Ireland
Diagnostics Division
Lisnamuck, Longford
Co. Longford
Ireland
+353-43-3331000
Abbott Laboratories
Abbott Park, IL 60064 USA
Customer Service: Contact your local representative
or find country-specific contact information on
[Link]
Revised December 2017.
©2016, 2017 Abbott Laboratories