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Health Canada Medical devices

Thermo Scientific™ RAPID™ Hp StAR™

Issued March 17, 2023
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
Hazard description
Medical devices
Product
Product name
Thermo Scientific™ RAPID™ Hp StAR™
Reference
ID
RA-73342