Quick summary
Quick summary: Crag Lateral Flow Assay.
Public recall detail
Crag Lateral Flow Assay
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Crag Lateral Flow Assay.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandImmy, Inc.
ProductCrag Lateral Flow Assay
IssueMedical devices - Lack of efficacy
Recall classType II
IdentificationRA-63823
Affected products
ProductCrag Lateral Flow Assay
LotF10100000001097
ModelCR2003
Serial numberF10100000001097
DescriptionCrag Lateral Flow Assay
Issue
The devices were found to have reduced specificity (90% now versus 99% before). Recall start date: Jan 3, 2022
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices
CompaniesImmy, Inc. 2701 Corporate Centre Drive, Norman, Oklahoma United States, 73069
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63823
Background{}
CompaniesImmy, Inc. 2701 Corporate Centre Drive, Norman, Oklahoma United States, 73069
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-17
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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