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OFFICIAL-SOURCE RECALL · AUSTRALIA

Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro Recall: 23/09/2026 Simplexa COVID-19 / Flu

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryAustraliaPublishedSeptember 23, 2026Last updatedSeptember 23, 2026Official source last checkedSeptember 27, 2026 at 7:44 PM UTC

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Is your product affected?

Brand
See official notice
Product
Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro diagnostic medical device (IVD).
Manufacturer
See official notice
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

23/09/2026 Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro diagnostic medical device (IVD). Medical Device Recall Class III Hospital

Hazard

23/09/2026 Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro diagnostic medical device (IVD). Medical Device Recall Class III Hospital

Official recall notice

Simplexa COVID-19 / Flu A/B & RSV Direct (MOL4450). An in vitro diagnostic medical device (IVD).

Agency: Therapeutic Goods Administration

Official publication date: September 23, 2026

Read the official AU_TGA_DRAC recall notice →

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