ms_12017717122V16.

T4 CalSet
12017717 122 4 x 1.0 mL
For USA: Elecsys CalSet T4

English Product safety labeling follows EU GHS guidance.

Intended use Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336
T4 CalSet is used for calibrating the quantitative Elecsys T4 assay on the Avoid foam formation in all reagents and sample types (specimens,
Elecsys and cobas e immunoassay analyzers. calibrators and controls).
Summary Handling
T4 CalSet is a buffer/protein matrix with added L‑thyroxine in two The calibrators are supplied ready‑for‑use in bottles compatible with the
concentration ranges. system.
The CalSet can be used with all reagent lots. cobas e 411 analyzer: The calibrators should only be left on the analyzer
during calibration at 20‑25 °C. After use, close the bottles as soon as
Reagents - working solutions possible and store upright at 2‑8 °C.
▪ T4 Cal1: 2 bottles, each containing 1.0 mL of calibrator 1 Due to possible evaporation effects, not more than 5 calibration procedures
▪ T4 Cal2: 2 bottles, each containing 1.0 mL of calibrator 2 per bottle set should be performed.
L‑thyroxine in two concentration ranges (approximately 50 nmol/L or MODULAR ANALYTICS E170, cobas e 601, cobas e 602 and
3.9 µg/dL and approximately 230 nmol/L or 17.9 µg/dL) in a buffer/protein cobas e 801 analyzers: Unless the entire volume is necessary for
(bovine serum albumin) matrix. calibration on the analyzers, transfer aliquots of the ready‑for‑use
cobas e 801 analyzer: The exact lot‑specific calibrator values are encoded calibrators into empty snap-cap bottles (CalSet Vials). Attach the supplied
in the electronic barcode and available via the cobas link. labels to these additional bottles. Store the aliquots at 2‑8 °C for later use.
All other analyzers: The exact lot‑specific calibrator values are encoded in Perform only one calibration procedure per aliquot.
the barcode as well as printed on the enclosed (or electronically available) Please note for cobas e 602 and cobas e 801 analyzers: Both the vial
calibrator barcode sheet. labels, and the additional labels (if available) contain 2 different barcodes.
Calibrator values Please turn the vial cap 180° into the correct position so that the barcode
between the yellow markers can be read by the system. Place the vial on
Traceability: The Elecsys T4 assay has been checked via ID‑GC/MS the analyzer as usual.
(isotope dilution‑gas chromatography/mass spectrometry) on various
control materials.1 Storage and stability
Precautions and warnings Store at 2‑8 °C.
For in vitro diagnostic use for health care professionals. Exercise the Stability:
normal precautions required for handling all laboratory reagents.
Infectious or microbial waste: unopened at 2‑8 °C up to the stated expiration date
Warning: handle waste as potentially biohazardous material. Dispose of after opening/in aliquots at 2‑8 °C 12 weeks
waste according to accepted laboratory instructions and procedures.
on cobas e 411 analyzer at up to 5 hours
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal. 20‑25 °C
Safety data sheet available for professional user on request. on MODULAR ANALYTICS E170, use only once
For USA: Caution: Federal law restricts this device to sale by or on the cobas e 601, cobas e 602 and
order of a physician. cobas e 801 analyzers at 20‑25 °C
This kit contains components classified as follows in accordance with the Store calibrators upright in order to prevent the calibrator solution from
Regulation (EC) No. 1272/2008: adhering to the snap‑cap.
Materials provided
▪ T4 CalSet, barcode card, calibrator barcode sheet, 2 x 6 bottle labels
Materials required (but not provided)
▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
Warning ▪ MODULAR ANALYTICS E170 or cobas e immunoassay analyzers and
H317 May cause an allergic skin reaction. Elecsys T4 assay reagents
See the assay Method Sheet and the operator’s manual for additionally
Prevention: required materials.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. Assay
Place the bottles in the sample zone.
P272 Contaminated work clothing should not be allowed out of Read in all the information necessary for calibrating the assay.
the workplace. Ensure the calibrators are at 20‑25 °C prior to measurement.
P280 Wear protective gloves. References
Response: 1 Thienpont LM, De Brabandere VI, Stöckl D, et al. Development of a
New Method for the Determination of Thyroxine in Serum Based on
P333 + P313 If skin irritation or rash occurs: Get medical Isotope Dilution Gas Chromatography Mass Spectrometry. Biological
advice/attention. Mass Spectrometry 1994;23:475-482.
For further information, please refer to the appropriate operator’s manual for
P362 + P364 Take off contaminated clothing and wash it before reuse. the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
Disposal: available in your country).
P501 Dispose of contents/container to an approved waste A point (period/stop) is always used in this Method Sheet as the decimal
disposal plant. separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.

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T4 CalSet
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, COBAS E and ELECSYS are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2021, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com
+800 5505 6606

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

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