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Cobas infinity central lab

Official notice

19 Apr 2023

Last checked

19 Apr 2023

Medium riskHealth Canada

An official Health Canada notice concerns Cobas infinity central lab. Under two very specific scenarios with Cobas e Flow configurations, the test may generate false positive or false negative results in the Cobas Infinity Central Lab. In Canada, none of their customers configured according to the impacted scenarios, therefore they are not impacted by the issue but are informed as a preventive action. Recall start date: April 11, 2023 Published 2023-04-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73538

Official notice

2023-04-19

The hazard

Under two very specific scenarios with Cobas e Flow configurations, the test may generate false positive or false negative results in the Cobas Infinity Central Lab. In Canada, none of their customers configured according to the impacted scenarios, therefore they are not impacted by the issue but are informed as a preventive action. Recall start date: April 11, 2023

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

73538

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Affected products

Product 1

Affected products - Cobas Infinity Central Lab, Lot or serial number - software versions 3.02.02 to 3.02.15 software versions 3.03.05 to 3.03.15, Model or catalog number - 09180443001 07154003001

Risk / hazard

Under two very specific scenarios with Cobas e Flow configurations, the test may generate false positive or false negative results in the Cobas Infinity Central Lab. In Canada, none of their customers configured according to the impacted scenarios, therefore they are not impacted by the issue but are informed as a preventive action. Recall start date: April 11, 2023

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 Infinity Central Lab.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73538

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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