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Unicel dxi 600 and 800 access immunoassay systems

Official notice

16 Dec 2025

Last checked

16 Dec 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Unicel dxi 600 and 800 access immunoassay systems. Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention. Published 2025-12-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81368

Official notice

2025-12-16

The hazard

Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Lots

900950, 902386, 900807, 901719, 902624, 900570, 902385, 902622, 901684, 902475

Skus

A71457, A71456, 973100, A71460, A71461, A30260

Other

RA RA-81368

Model Numbers

A71457, A71456, 973100, A71460, A71461, A30260

Recall Numbers

81368

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Affected products

Product 1

Affected products - UniCel DxI 800 Access Immunoassay - Analyzer-Class 3, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71457

Product 2

Affected products - UniCel DxI 800 Access Immunoassay - Analyzer-Class 3, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71456

Product 3

Affected products - UniCel DxI 800 Access Immunoassay - Analyzer-Class 3, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 973100

Product 4

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 900950, Model or catalogue number - A30260

Product 5

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 902386, Model or catalogue number - A30260

Product 6

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 900807, Model or catalogue number - A30260

Product 7

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 901719, Model or catalogue number - A30260

Product 8

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 902624, Model or catalogue number - A30260

Product 9

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 900570, Model or catalogue number - A30260

Product 10

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 902385, Model or catalogue number - A30260

Product 11

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 902622, Model or catalogue number - A30260

Product 12

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 901684, Model or catalogue number - A30260

Product 13

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 3, Lot or serial number - 902475, Model or catalogue number - A30260

Product 14

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 900950, Model or catalogue number - A30260

Product 15

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 902386, Model or catalogue number - A30260

Product 16

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 900807, Model or catalogue number - A30260

Product 17

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 901719, Model or catalogue number - A30260

Product 18

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 902624, Model or catalogue number - A30260

Product 19

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 902385, Model or catalogue number - A30260

Product 20

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 900570, Model or catalogue number - A30260

Product 21

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 902622, Model or catalogue number - A30260

Product 22

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 901684, Model or catalogue number - A30260

Product 23

Affected products - UniCel DxI 600 Access Immunoassay System, Lot or serial number - 902475, Model or catalogue number - A30260

Product 24

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 900950, Model or catalogue number - A30260

Product 25

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 902386, Model or catalogue number - A30260

Product 26

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 900807, Model or catalogue number - A30260

Product 27

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 901719, Model or catalogue number - A30260

Product 28

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 902624, Model or catalogue number - A30260

Product 29

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 900570, Model or catalogue number - A30260

Product 30

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 902385, Model or catalogue number - A30260

Product 31

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 902622, Model or catalogue number - A30260

Product 32

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 901684, Model or catalogue number - A30260

Product 33

Affected products - UniCel DxI 600 Access Immunoassay System - Instrument Class 2, Lot or serial number - 902475, Model or catalogue number - A30260

Product 34

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71457

Product 35

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71456

Product 36

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 973100

Product 37

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71460

Product 38

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71461

Product 39

Lot or serial number - 900950, Model or catalogue number - A30260

Product 40

Lot or serial number - 902386, Model or catalogue number - A30260

Product 41

Lot or serial number - 900807, Model or catalogue number - A30260

Product 42

Lot or serial number - 901719, Model or catalogue number - A30260

Product 43

Lot or serial number - 902624, Model or catalogue number - A30260

Product 44

Lot or serial number - 900570, Model or catalogue number - A30260

Product 45

Lot or serial number - 902385, Model or catalogue number - A30260

Product 46

Lot or serial number - 902622, Model or catalogue number - A30260

Product 47

Lot or serial number - 901684, Model or catalogue number - A30260

Product 48

Lot or serial number - 902475, Model or catalogue number - A30260

Risk / hazard

Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention.

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Beckman Coulter

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81368

Classification

Type 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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