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Instrumentation Laboratory HemosIL LMW Heparin Controls; Part Number: 0020300200 - safety alert

Official notice

20 Aug 2025

MediumFDA

An official FDA notice concerns HemosIL LMW Heparin Controls; Part Number: 0020300200. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-08-20. Lots: N0330228. Recall numbers: Z-2323-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

41,824

Recall number

Z-2323-2025

Official notice

2025-08-20

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.

Lots

N0330228

Other

UDI-DI 08426950472490

Event Ids

97093

Recall Numbers

Z-2323-2025

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Affected products

Product 1

HemosIL LMW Heparin Controls; Part Number: 0020300200

Units affected

41,824

Risk / hazard

Health risk requiring medical assessment

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

CR · Costa Rica

Affected area 13

CZ · Czech Republic

Affected area 14

DE · Germany

Affected area 15

DK · Denmark

Affected area 16

ES · Spain

Affected area 17

FI · Finland

Affected area 18

GB · United Kingdom

Affected area 19

GR · Greece

Affected area 20

GT · Guatemala

Affected area 21

HK · Hong Kong

Affected area 22

HU · Hungary

Affected area 23

IE · Ireland

Affected area 24

IL · Israel

Affected area 25

IN · India

Affected area 26

IT · Italy

Affected area 27

JP · Japan

Affected area 28

KR · South Korea

Affected area 29

KW · Kuwait

Affected area 30

LT · Lithuania

Affected area 31

MX · Mexico

Affected area 32

MY · Malaysia

Affected area 33

PE · Peru

Affected area 34

PL · Poland

Affected area 35

PT · Portugal

Affected area 36

RO · Romania

Affected area 37

RS · Serbia

Affected area 38

RU · Russia

Affected area 39

SA · Saudi Arabia

Affected area 40

SE · Sweden

Affected area 41

TH · Thailand

Affected area 42

TR · Turkey

Affected area 43

UY · Uruguay

Affected area 44

VN · Vietnam

Affected area 45

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Instrumentation Laboratory. Contact: Instrumentation Laboratory.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2323-2025

Event id

97093

Units affected

41,824

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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