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Vitros chemistry products versatips
Official notice
1 Jan 2022
Last checked
1 Jan 2022
An official Health Canada notice concerns Vitros chemistry products versatips. Ortho received complaints and confirmed that there is potential for deformed Versatip with lot 1039734. This deformity can lead to an improper seal of the tip on the Proboscis. An improperly sealed tip may cause a condition code to post but will not always post a condition code or suppress result reporting. This issue does not impact microslide assay results. However, it has potential to cause a positive or negative bias in some microtip and microwell infectious disease assays leading to false positive or false negative results for samples with borderline signal cutoff values. Recall start date: 2021-12-14 Published 2022-01-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63782
Official notice
2022-01-01
The hazard
The hazard
Ortho received complaints and confirmed that there is potential for deformed Versatip with lot 1039734. This deformity can lead to an improper seal of the tip on the Proboscis. An improperly sealed tip may cause a condition code to post but will not always post a condition code or suppress result reporting. This issue does not impact microslide assay results. However, it has potential to cause a positive or negative bias in some microtip and microwell infectious disease assays leading to false positive or false negative results for samples with borderline signal cutoff values. Recall start date: 2021-12-14
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.
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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.
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Affected area 1
Company & contacts
Company & contacts
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Brand: Ortho-clinical Diagnostics, Vitros Chemistry Versatips.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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