Central Drugs Standard Control Organization Directorate General of Health Services Government of India (Medical Device Division) Food & Drugs Administration Bhavan, Kotla Rad, New Delhi File No: 4/8-1N/2010-DC (01) End 04 Dato: 10.12.2013 biaGNostic KIT ALERT Product BBL™ MGIT™ Mycobacteria Growth Indicator Tube (Lot No. 3042467) ‘BACKGROUND i BBL™ MGIT™ Mycobacteria Growth indicator Tube supplemented with BACTEC™ MGIT™ growth supplement and B8L"™ MBIT™ PANTA™ antibiotic mixture is intended for detection snd recovery of mycobacteria using the BACTEC™ MGIT™ 960 and BACTEC'™ MGIT""320 sysidms Acceptance specimen types. are digested and decontaminated clical (oxeeat urine) end serie body fuslexcept blood) PROBLEM 2 Voluntary recall of the BBL"™ MGIT™ Mycobacteria Growth Indicator Tube ( Lot No. 3042467) due to a portion of tié tubes of the product contain an incorrect prefix on the barcode label, The Incorrect pfefix begins vith "43 02" instead of the required "43 01”. The instrument BACTEC™ MCAT may report an incorect result fer growih and detection functon. ACTION BY > Medical directors! Healthcare Professionals > Staff involved in the manegement of pationts > Diagnostics Labs Page of 2> Do not use the BBL™ MGIT™ Mycobacteria Growth Indicator Tube (Lot No, 3042467) > Retum all unused product to the manufacturer. ADVERSE EFFECTS The BACTEC™ MGIT™ instrument may repor an incocect result for growth and detection ‘uncton. 11800 pieces of BBL™ NGIT™ Mycobacteria Growth indicator Tube has been imported in Incia. Cut of which 7100 pieces been recalled by the M/s Becton & Dickinson til 13- s0p-2013. contacts 1, Mls Becton Dickinson and Company,7 Loveton Circle, Sparks, Maryland, 21152,USA, = Mis Becton DickineoA, India Pvt Lid, No. 34 Assiel Nagar, West Thottam, Madhavaram,Chennai-54 . Central Drugs Standard Control Organization, Directorate General of Health Services, Minsky of Hebity and Family Welfare, Government of India, FDA Bhavan, iTO, Kotla Road, New Delhi 110002 Tel: 91-11-2529078 / 25430971 Fax 91-11-23296073} small ecl@nbinien Page 20f2 =