Open official notice

Safety warnings concerning the Aptiva CTD Essential Reagent assay, reference 723100, because the indication for the pediatric population has been removed and the instructions for use now specify that its intended use is in adult populations.

Official notice

30 Oct 2026

Last checked

30 Oct 2026

RecallScope risk estimate:Not specifiedAEMPS

An official AEMPS notice concerns Safety warnings concerning the Aptiva CTD Essential Reagent assay, reference 723100, because the indication for the pediatric population has been removed and the instructions for use now specify that its intended use is in adult populations.. Safety warnings concerning the Aptiva CTD Essential Reagent assay, reference 723100, because the indication for the pediatric population has been removed and the instructions for use now specify that its intended use is in adult populations. Published 2026-10-30.

What to do now

Consumer instructions are not currently available in RecallScope. Check the official notice for what to do.

Recall number

2026-531

Official notice

2026-10-30

The hazard

Safety warnings concerning the Aptiva CTD Essential Reagent assay, reference 723100, because the indication for the pediatric population has been removed and the instructions for use now specify that its intended use is in adult populations.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.

Other

UDI-DI 08430793040051, PS/RJC/145336

Part Numbers

723100

Recall Numbers

2026-531

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Affected products

Product 1

Aptiva CTD Essential Reagent. Referencia 723100. UDI-DI: 08430793040051.

Hazard

Safety warnings concerning the Aptiva CTD Essential Reagent assay, reference 723100, because the indication for the pediatric population has been removed and the instructions for use now specify that its intended use is in adult populations.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

ES · Spain

Affected area 1

ES · Spain

Source & status

Source

Tier

official

Category

HEALTH

Official classification

AEMPS — Alerta de vigilancia de productos sanitarios (tipo 2A)

Recall details

Recall number

2026-531

Event id

2026-531

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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