Open official notice

Stop using certain lots of Access HIV Ag/Ab Combo calibrator kits due to the possibility of false positive or false negative results because of an error in the calibration card barcodes, whereby the values assigned to the HIV-Ag calibrator are attributed to the HIV-Ab assay and vice versa.

Official notice

30 Oct 2026

Last checked

30 Oct 2026

RecallScope risk estimate:Not specifiedAEMPS

An official AEMPS notice concerns Stop using certain lots of Access HIV Ag/Ab Combo calibrator kits due to the possibility of false positive or false negative results because of an error in the calibration card barcodes, whereby the values assigned to the HIV-Ag calibrator are attributed to the HIV-Ab assay and vice versa.. Stop using certain lots of Access HIV Ag/Ab Combo calibrator kits due to the possibility of false positive or false negative results because of an error in the calibration card barcodes, whereby the values assigned to the HIV-Ag calibrator are attributed to the HIV-Ab assay and vice versa. 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

2026-529

Official notice

2026-10-30

The hazard

Stop using certain lots of Access HIV Ag/Ab Combo calibrator kits due to the possibility of false positive or false negative results because of an error in the calibration card barcodes, whereby the values assigned to the HIV-Ag calibrator are attributed to the HIV-Ab assay and vice versa.

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 15099590745165, PS/AVG/146359

Part Numbers

C39451

Recall Numbers

2026-529

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Affected products

Product 1

Calibrador Access HIV Ag/Ab Combo. Número de referencia: C39451. UDI: 15099590745165.

Hazard

Stop using certain lots of Access HIV Ag/Ab Combo calibrator kits due to the possibility of false positive or false negative results because of an error in the calibration card barcodes, whereby the values assigned to the HIV-Ag calibrator are attributed to the HIV-Ab assay and vice versa.

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 1A)

Recall details

Recall number

2026-529

Event id

2026-529

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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