Musculoskeletal Tissue - Metro South Hospital and Health Service T/A Queensland Tissue Bank, Metro South Hospital and Health Service T/A Queensland Tissue Bank, CON-1175
Product name
Musculoskeletal Tissue - Metro South Hospital and Health Service T/A Queensland Tissue Bank
Sponsor name
Metro South Hospital and Health Service T/A Queensland Tissue Bank
Batches
PB221213A, PB230130D, PB230207P, PB230412E, PB230503H, PB230517F, PB230531C, PB230606A
Consent start
Consent no.
CON-1175
Duration
The consent is effective from 30 October 2023 until 1 June 2027.
Standard
Clause 22 of Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021
Non-compliance with standard
The products will not comply with the requirement, in that demineralised bone
matrix (DBM) products specified below, have residual calcium levels in excess of
8% w/w.
Conditions imposed
That the sponsor provides information to the end user of these batches
indicating that the batches contain higher than expected residual calcium
levels.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals