OFFICIAL-SOURCE RECALL · AUSTRALIA
All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 Recall: 21/08/2026 All GEM PAKs for GEM
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD).
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
21/08/2026 All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD). Medical Device Product Correction Class II Hospital
Hazard
21/08/2026 All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD). Medical Device Product Correction Class II Hospital
Official recall notice
All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD).
Agency: Therapeutic Goods Administration
Official publication date: August 21, 2026
Read the official AU_TGA_DRAC recall notice →SCAN ONCE. KEEP WATCHING.
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