Open official notice

Stop using certain lots and references of StatStrip ketone strips due to an increase in quality control test failures, which may contribute to delays in obtaining patients' ketone results.

Official notice

6 Nov 2026

Last checked

6 Nov 2026

RecallScope risk estimate:MediumAEMPS

An official AEMPS notice concerns Stop using certain lots and references of StatStrip ketone strips due to an increase in quality control test failures, which may contribute to delays in obtaining patients' ketone results.. Stop using certain lots and references of StatStrip ketone strips due to an increase in quality control test failures, which may contribute to delays in obtaining patients' ketone results. Published 2026-11-06.

What to do now

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

Recall number

2026-538

Official notice

2026-11-06

The hazard

Stop using certain lots and references of StatStrip ketone strips due to an increase in quality control test failures, which may contribute to delays in obtaining patients' ketone results.

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

PS/EML/146051

Part Numbers

46951, 54288, 55932, 66841

Recall Numbers

2026-538

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Affected products

Product 1

Tiras de Cetona StatStrip para pruebas de control de calidad

Product 2

TEST STRIP 50CT KET STRIP DUAL PACK. Referencia: 46951

Product 3

TEST STRIP 20CT KET STRIP NIPRO. Referencia: 54288

Product 4

TEST STRIP 50CT KET STRIP LIFESCAN. Referencia: 55932

Product 5

TEST STRIP 50CT KET CA STATSTRIP. Referencia: 66841

Hazard

Stop using certain lots and references of StatStrip ketone strips due to an increase in quality control test failures, which may contribute to delays in obtaining patients' ketone results.

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

2026-538

Event id

2026-538

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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