Public recall detail

Thermo Scientific™ RAPID™ Hp StAR™

2023-03-17

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Recall Safety notice
Quick summary

Quick summary: Thermo Scientific™ RAPID™ Hp StAR™. Date: 2023-03-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Thermo Scientific™ RAPID™ Hp StAR™. Date: 2023-03-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOxoid Limited
ProductThermo Scientific™ RAPID™ Hp StAR™
IssueMedical devices
Recall classType II
IdentificationRA-73342

Affected products

ProductThermo Scientific™ RAPID™ Hp StAR™
Lot3615769 3553024
ModelK671411-2
Serial number3615769 3553024
DescriptionThermo Scientific™ RAPID™ Hp StAR™

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Microbiology
CompaniesOxoid Limited Wade Road, Basingstoke, Hampshire, Great Britain, RG24 8PW
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73342
Background{}
CompaniesOxoid Limited Wade Road, Basingstoke, Hampshire, Great Britain, RG24 8PW
AudiencesHealthcare
Source updated2023-03-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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