OFFICIAL-SOURCE RECALL · AUSTRALIA
MicroVue SC5b-9 Plus EIA. An in vitro diagnostic medical device Recall: Classification Class II Reason for
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- MicroVue SC5b-9 Plus EIA. An in vitro diagnostic medical device (IVD)
- Manufacturer
- See official notice
- Lot number
- numbers, 13020221, and, to-lot, may
- Batch number
- numbers
- Date code
- dates, 28-FEB-2027
- Expiration date
- dates, 28-FEB-2027
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 received complaints about discrepancies in patient correlation results with percent differences compared to the previous lot. We have confirmed a high bias between samples from the previous lot and lot 13020221. The observed lot-to-lot bias affects plasma samples with SC5b-9 concentrations approximately between 88 ng/mL and 260 ng/mL. Within this range, results generated with the affected reagent lot may be positively biased, with an average observed bias of approximately +46.8%. Falsely elevated patient results could result in inappropriate demonstration of elevated terminal complement activation, which could impact patient management. As of 27 July 2026, QuidelOrtho has received 4 complaints relating to this problem with no reports of adverse effects. Instructions for Customers/Users Customers are to: - Discontinue use, render unusable, and discard all remaining inventory of affected stock. - Review the content of the Customer Letter with a Medical Director. - Complete and return the Confirmation of Receipt form. Action Commencement Date 19/08/2026 Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Hazard
Classification Class II Reason for the Action QuidelOrtho received complaints about discrepancies in patient correlation results with percent differences compared to the previous lot. We have confirmed a high bias between samples from the previous lot and lot 13020221. The observed lot-to-lot bias affects plasma samples with SC5b-9 concentrations approximately between 88 ng/mL and 260 ng/mL. Within this range, results generated with the affected reagent lot may be positively biased, with an average observed bias of approximately +46.8%. Falsely elevated patient results could result in inappropriate demonstration of elevated terminal complement activation, which could impact patient management. As of 27 July 2026, QuidelOrtho has received 4 complaints relating to this problem with no reports of adverse effects. Instructions for Customers/Users Customers are to: - Discontinue use, render unusable, and discard all remaining inventory of affected stock. - Review the content of the Customer Letter with a Medical Director. - Complete and return the Confirmation of Receipt form. Action Commencement Date 19/08/2026 Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Official recall notice
MicroVue SC5b-9 Plus EIA. An in vitro diagnostic medical device (IVD)
Agency: Therapeutic Goods Administration
Official publication date: July 27, 2026
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