OFFICIAL-SOURCE RECALL · AUSTRALIA
All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 Recall: Classification Class II Reason for
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
- Lot number
- numbers
- Batch number
- numbers
- Date code
- dates
- Expiration date
- dates
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
Classification Class II Reason for the Action Following customer reports, a review of sodium (Na+) results from normal patient populations on the GEM Premier 5000 and GEM Premier 7000 systems shows a negative bias of approximately 3 mmol/L relative to the
Hazard
Classification Class II Reason for the Action Following customer reports, a review of sodium (Na+) results from normal patient populations on the GEM Premier 5000 and GEM Premier 7000 systems shows a negative bias of approximately 3 mmol/L relative to the
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
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