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BACTEC™ Supplement/F Media Supplement is a required supplement to MYCO/F-Sputa Medium for the recovery of mycobacteria. In addition, it is used to reconstitute PANTA™/F Antimicrobial Supplement. Principal use is with MYCO/F-Sputa Medium and with the BACTEC brand 9000MB instrument.

Supplement/F is used to reconstitute PANTA/F Antimicrobial Supplement. The reconstituted fluid is then added to each MYCO/F-Sputa Medium vial prior to specimen inoculation. Supplement/F contains essential nutrients for the growth and detection of mycobacteria and therefore is a required supplement to MYCO/F-Sputa Medium even if PANTA/F antibiotics are not needed. The MYCO/F-Sputa Medium culture vial is incubated and tested in a BACTEC 9000MB instrument for the detection of mycobacteria.

Do not use vials past their expiration date.

DO NOT use vials that exhibit any cracks or defects; discard the vial in the appropriate manner.

Quality Control Certificates are provided with each kit of BACTEC Supplement/F media. Quality Control Certificates show test organisms utilized for this type of product.

For information on quality control for the BACTEC 9000MB instrument, refer to the BACTEC 9000MB User's Manual (MA-0092).

See BACTEC MYCO/F-Sputa Medium package insert, (PP101JAA), for medium quality control.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent NCCLS guidance and CLIA regulations for appropriate Quality Control practices.

Supplement/F vials contain the following active ingredients prior to processing:

For in vitro diagnostic use.

This Product Contains Dry Natural Rubber.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^1-4 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Prior to use, the user should examine the vials for evidence of damage or deterioration. Vials that exhibit evidence of damage should be discarded prior to inoculation. Vials displaying turbidity, contamination, or discoloration (darkening) should not be used. On rare occasions, the glass bottle neck may be cracked and the neck may break during removal of the flip-off cap or in handling. Also, on rare occasions a vial may not be sealed sufficiently. In both cases the contents of the vials may leak or spill.

For use with MYCO/F-Sputa Medium; read and follow instructions and information supplied with that product.

Reconstitute the PANTA/F vial only with Supplement/F. DO NOT add the supplemented fluid to MYCO/F-Sputa Medium culture vials more than 2 h prior to the inoculation of the specimen.