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Cobas analytical and supply unit

Official notice

15 Aug 2022

Last checked

15 Aug 2022

Medium riskHealth Canada

An official Health Canada notice concerns Cobas analytical and supply unit. Manufacturer internally detected a potential operational software issue affecting Cobas Pure E 402, Cobas Pro and/or Cobas 8000 E 801 instruments. The issue may occur under specific instrument conditions and sequence of laboratory actions when the quick start mode is activated on the instrument. Recall start date: July 18, 2022 Published 2022-08-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64467

Official notice

2022-08-15

The hazard

Manufacturer internally detected a potential operational software issue affecting Cobas Pure E 402, Cobas Pro and/or Cobas 8000 E 801 instruments. The issue may occur under specific instrument conditions and sequence of laboratory actions when the quick start mode is activated on the instrument. Recall start date: July 18, 2022

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.

Recall Numbers

64467

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Affected products

Product 1

Affected products - Cobas E 402 Analytical Unit, Lot or serial number - 2131-08 2112-03 2131-05 2144-10, Model or catalogue number - 09031553001

Product 2

Affected products - Cobas 8000 E 801, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 07682913001

Product 3

Affected products - Cobas E 801 Analytical Unit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 08454345001

Product 4

Affected products - Cobas 8000 Core Unit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 05641446001

Product 5

Affected products - Cobas Pure Sample Supply Unit, Lot or serial number - 2142-01 2114-04 2146-07 2141-08, Model or catalogue number - 09031537001

Product 6

Affected products - Cobas Pro Sample Supply Unit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 08464502001 09205632001

Risk / hazard

Manufacturer internally detected a potential operational software issue affecting Cobas Pure E 402, Cobas Pro and/or Cobas 8000 E 801 instruments. The issue may occur under specific instrument conditions and sequence of laboratory actions when the quick start mode is activated on the instrument. Recall start date: July 18, 2022

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Roche Diagnostics, Cobas Analytical And Supply Unit.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64467

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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