Recalls and suspensions

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18 October 2018
TGA web statment on the post-market review of heater-coolers has been updated
28 September 2018
Update - suspension revoked
23 September 2018
Recall - possible microbial contamination
1 August 2018
Recall - single batch does not pass shelf life durability tests

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Safety information

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22 October 2018
Medicine shortage – product supplied under section 19A
8 October 2018
Update 3 - continuing medicine shortage
8 October 2018
Update 3 - continuing medicine shortage
26 September 2018
Case studies in Incident Report Investigations; review of reusable biopsy forceps devices; care required with patient lifters

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News

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23 October 2018
Updated supporting data form for TGA conformity assessment applications
23 October 2018
The TGA is seeking comments on a proposal for the regulation of IVD companion diagnostics. Closing date: 4 December 2018
23 October 2018
ARGMD landing page updated with links to new guidance
23 October 2018
Transition to eCTD Only for Prescription Medicines now open for public consultation. Closing date: 4 December 2018

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