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Atellica CH Enzymatic Hemoglobin A1c (A1c E). Material Number: 11097536

Official notice

15 Jul 2026

Last checked

22 Sept 2026

MediumFDA

An official FDA notice concerns Siemens Healthcare Diagnostics. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-07-15. Recall numbers: Z-2703-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

24,077

Recall number

Z-2703-2026

Official notice

2026-06-08

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 00630414220505

Event Ids

99214

Recall Numbers

Z-2703-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AR · Argentina

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BG · Bulgaria

Affected area 6

BR · Brazil

Affected area 7

CA · Canada

Affected area 8

CH · Switzerland

Affected area 9

CL · Chile

Affected area 10

CN · China

Affected area 11

CO · Colombia

Affected area 12

DE · Germany

Affected area 13

DK · Denmark

Affected area 14

EE · Estonia

Affected area 15

EG · Egypt

Affected area 16

ES · Spain

Affected area 17

FI · Finland

Affected area 18

FR · France

Affected area 19

GR · Greece

Affected area 20

HK · Hong Kong

Affected area 21

HR · Croatia

Affected area 22

IL · Israel

Affected area 23

IN · India

Affected area 24

IT · Italy

Affected area 25

JO · Jordan

Affected area 26

JP · Japan

Affected area 27

KR · South Korea

Affected area 28

KW · Kuwait

Affected area 29

LT · Lithuania

Affected area 30

LV · Latvia

Affected area 31

MX · Mexico

Affected area 32

MY · Malaysia

Affected area 33

NL · Netherlands

Affected area 34

NO · Norway

Affected area 35

NZ · New Zealand

Affected area 36

PK · Pakistan

Affected area 37

PL · Poland

Affected area 38

PT · Portugal

Affected area 39

RO · Romania

Affected area 40

RS · Serbia

Affected area 41

SG · Singapore

Affected area 42

SI · Slovenia

Affected area 43

SK · Slovakia

Affected area 44

SV · El Salvador

Affected area 45

TH · Thailand

Affected area 46

TR · Turkey

Affected area 47

UY · Uruguay

Affected area 48

VN · Vietnam

Affected area 49

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens Healthcare Diagnostics. Contact: Siemens Healthcare Diagnostics, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2703-2026

Event id

99214

Units affected

24,077

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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