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
ARTG
Batches
PB221213A, PB230130D, PB230207P, PB230412E, PB230503H, PB230517F, PB230531C, PB230606A
Consent start
Consent no.
CON-1175
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.
Therapeutic product type
Blood, tissues, and biologicals