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Vitros® systems
Official notice
7 Mar 2024
Last checked
7 Mar 2024
An official Health Canada notice concerns Vitros® systems. Some serial numbers of the Vitros® systems as listed above may experience an anomaly involving the sampling center, which may have been manufactured using a sub-optimal hardware part. Quidelortho confirmed a complaint where the sampling center mechanism unintentionally disengaged from the universal sample tray (tray), resulting in the misalignment of the intended sample container to be aspirated. From our investigation of this single occurrence, Quidelortho determined that if this disengagement and misalignment occurs, it may cause one or multiple patient samples to be aspirated from an unintended sample container within the same tray and report the results using the incorrect patient samples. Based on the investigation, Quidelortho estimates the likelihood of this occurrence to be approximately 0.00000035% (or about 1 in 2.88 million tests.) Recall start date: January 26, 2024 Published 2024-03-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75187
Official notice
2024-03-07
The hazard
The hazard
Some serial numbers of the Vitros® systems as listed above may experience an anomaly involving the sampling center, which may have been manufactured using a sub-optimal hardware part. Quidelortho confirmed a complaint where the sampling center mechanism unintentionally disengaged from the universal sample tray (tray), resulting in the misalignment of the intended sample container to be aspirated. From our investigation of this single occurrence, Quidelortho determined that if this disengagement and misalignment occurs, it may cause one or multiple patient samples to be aspirated from an unintended sample container within the same tray and report the results using the incorrect patient samples. Based on the investigation, Quidelortho estimates the likelihood of this occurrence to be approximately 0.00000035% (or about 1 in 2.88 million tests.) Recall start date: January 26, 2024
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
Product 2
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: Ortho-clinical Diagnostics, Vitros®.
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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