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Alinity i homocysteine reagent kit
Official notice
4 Apr 2022
Last checked
4 Apr 2022
An official Health Canada notice concerns Alinity i homocysteine reagent kit. The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results. If your laboratory has established statistically‐based control limits at each clinically relevant control level, your controls will detect the shift out of range. If quality control results do not meet the acceptance criteria defined by your laboratory, sample results may be suspect and should not be reported. Recall start date: Mar 25, 2022 Published 2022-04-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64044
Official notice
2022-04-04
The hazard
The hazard
The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results. If your laboratory has established statistically‐based control limits at each clinically relevant control level, your controls will detect the shift out of range. If quality control results do not meet the acceptance criteria defined by your laboratory, sample results may be suspect and should not be reported. Recall start date: Mar 25, 2022
How to check if you're affected
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
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Abbott, Alinity I Homocysteine Reagent Kit.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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