ms_08443459160_USAV2.

TSH CalSet
08443459160 4 x 1.3 mL

English Product safety labeling follows EU GHS guidance.

For use in the USA only Contact phone: 1-800-428-2336
All human material should be considered potentially infectious. All products
Intended use derived from human blood are prepared exclusively from the blood of
TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on donors tested individually and shown to be free from HBsAg and antibodies
cobas e immunoassay analyzers. to HCV and HIV. The testing methods use assays that have been approved
by the FDA or that are in compliance with the legal rules applicable to
Summary placing in vitro diagnostic medical devices for human use on the market in
TSH CalSet is an equine serum matrix (TSH Cal1) and a human serum the European Union.
matrix with human TSH (TSH Cal2) in two concentration ranges. However, as no testing method can rule out the potential risk of infection
The CalSet can be used with all reagent lots. with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the
Reagents - working solutions responsible health authorities should be followed.1,2
▪ TSH Cal1: 2 bottles, each containing 1.3 mL of calibrator 1 Avoid foam formation in all reagents and sample types (specimens,
▪ TSH Cal2: 2 bottles, each containing 1.3 mL of calibrator 2 calibrators and controls).
The concentration of TSH Cal1 in the equine serum matrix is approximately Handling
0 μIU/mL; TSH Cal2 contains approximately 1.5 μIU/mL TSH (human) in The calibrators are supplied ready‑for‑use in bottles compatible with the
the human serum matrix. system.
cobas e 402 and cobas e 801 analyzers: The exact lot‑specific calibrator cobas e 411 analyzer: The calibrators should only be left on the analyzer
values are encoded in the electronic barcode and available via the during calibration at 20‑25 °C. After use, close the bottles as soon as
cobas link. possible and store upright at 2‑8 °C.
All other analyzers: The exact lot‑specific calibrator values are encoded in
the barcode as well as printed on the enclosed (or electronically available) Due to possible evaporation effects, not more than 5 calibration procedures
calibrator barcode sheet. per bottle set should be performed.
cobas e 402, cobas e 601, cobas e 602 and cobas e 801 analyzers:
Calibrator values Unless the entire volume is necessary for calibration on the analyzers,
Traceability: The Elecsys TSH assay has been standardized against the transfer aliquots of the ready‑for‑use calibrators into empty snap‑cap bottles
2nd IRP WHO Reference Standard 80/558. (CalSet Vials). Attach the supplied labels to these additional bottles. Store
Precautions and warnings the aliquots at 2‑8 °C for later use.
For in vitro diagnostic use for health care professionals. Exercise the Perform only one calibration procedure per aliquot.
normal precautions required for handling all laboratory reagents. Please note for cobas e 402, cobas e 602 and cobas e 801 analyzers:
Infectious or microbial waste: Both the vial labels, and the additional labels (if available) contain 2
Warning: handle waste as potentially biohazardous material. Dispose of different barcodes. Please turn the vial cap 180° into the correct position so
waste according to accepted laboratory instructions and procedures. that the barcode between the yellow markers can be read by the system.
Place the vial on the analyzer as usual.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal. Storage and stability
Safety data sheet available for professional user on request. Store at 2‑8 °C.
For USA: Caution: Federal law restricts this device to sale by or on the Stability:
order of a physician.
This kit contains components classified as follows in accordance with the unopened at 2‑8 °C up to the stated expiration date
Regulation (EC) No. 1272/2008: after opening/in aliquots at 2‑8 °C 12 weeks
on cobas e 411 analyzer at up to 5 hours
20‑25 °C
on cobas e 402, cobas e 601, use only once
cobas e 602 and cobas e 801
Warning analyzers at 20‑25 °C

H317 May cause an allergic skin reaction. Store calibrators upright in order to prevent the calibrator solution from
adhering to the snap‑cap.
Prevention:
Materials provided
P261 Avoid breathing mist or vapours. ▪ TSH CalSet, barcode card, calibrator barcode sheet, 2 x 4 bottle labels
Materials required (but not provided)
P272 Contaminated work clothing should not be allowed out of
the workplace. ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
▪ cobas e immunoassay analyzers and Elecsys TSH assay reagents
P280 Wear protective gloves. See the assay Method Sheet and the operator’s manual for additionally
Response: required materials.
Assay
P333 + P313 If skin irritation or rash occurs: Get medical
Place the bottles in the sample zone.
advice/attention.
Read in all the information necessary for calibrating the assay.
P362 + P364 Take off contaminated clothing and wash it before reuse. Ensure the calibrators are at 20‑25 °C prior to measurement.
Disposal: References
1 Occupational Safety and Health Standards: Bloodborne pathogens.
P501 Dispose of contents/container to an approved waste (29 CFR Part 1910.1030). Fed. Register.
disposal plant.

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TSH CalSet
2 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets and the Method
Sheets of all necessary components (if available in your country).
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 for reconstitution
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.
© 2022, 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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