OFFICIAL-SOURCE RECALL · AUSTRALIA
VITROS Chemistry Products VALP Reagent. An in vitro diagnostic Recall: Classification Class II Reason for
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Is your product affected?
- Brand
- See official notice
- Product
- VITROS Chemistry Products VALP Reagent. An in vitro diagnostic medical device (IVD).
- Manufacturer
- See official notice
- Lot number
- numbers
- Batch number
- numbers
- Date code
- dates, 17-Aug-2026
- Expiration date
- dates, 17-Aug-2026
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 QuidelOrtho confirmed a problem involving VITROS Chemistry Products VALP Reagent. Lots from Generations (GENs) 35, 36, and 37 may generate positively biased results. QuidelOrtho’s investigation into the problem determined that lots from GENs 35, 36, and 37 of VITROS VALP Reagent may experience a drift in performance across the shelf life of the product. A drift in performance may cause positively biased results as the product ages. To date, no adverse events have been reported due to this problem. Instructions for Customers/Users Customers are to: • Discontinue using, render unusable, and discard all inventory of affected lots of VITROS VALP Reagent. • Complete the Customer Response Form. QuidelOrtho will credit or replace discarded inventory. Action Commencement Date 14/08/2026 Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Hazard
Classification Class II Reason for the Action QuidelOrtho confirmed a problem involving VITROS Chemistry Products VALP Reagent. Lots from Generations (GENs) 35, 36, and 37 may generate positively biased results. QuidelOrtho’s investigation into the problem determined that lots from GENs 35, 36, and 37 of VITROS VALP Reagent may experience a drift in performance across the shelf life of the product. A drift in performance may cause positively biased results as the product ages. To date, no adverse events have been reported due to this problem. Instructions for Customers/Users Customers are to: • Discontinue using, render unusable, and discard all inventory of affected lots of VITROS VALP Reagent. • Complete the Customer Response Form. QuidelOrtho will credit or replace discarded inventory. Action Commencement Date 14/08/2026 Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Official recall notice
VITROS Chemistry Products VALP Reagent. An in vitro diagnostic medical device (IVD).
Agency: Therapeutic Goods Administration
Official publication date: August 14, 2026
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