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Thermo scientific™ rapid™ hp star™

Official notice

17 Mar 2023

Last checked

17 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Thermo scientific™ rapid™ hp star™. Thermo scientific™ Hp StaR™ lateral flow kits are failing to meet IFU criteria with multiple strip giving false positive results with known negative samples and also false positive result on substrate diluent. Recall start date: March 10, 2023 Published 2023-03-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73342

Official notice

2023-03-17

The hazard

Thermo scientific™ Hp StaR™ lateral flow kits are failing to meet IFU criteria with multiple strip giving false positive results with known negative samples and also false positive result on substrate diluent. Recall start date: March 10, 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

73342

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Affected products

Product 1

Affected products - Thermo Scientific™ RAPID™ Hp StAR™, Lot or serial number - 3615769 3553024, Model or catalog number - K671411-2

Risk / hazard

Thermo scientific™ Hp StaR™ lateral flow kits are failing to meet IFU criteria with multiple strip giving false positive results with known negative samples and also false positive result on substrate diluent. Recall start date: March 10, 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: Oxoid, HP.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73342

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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