Vitros Chemistry Products Versatips
Brand(s)
Last updated
Summary
Product
Vitros Chemistry Products Versatips
Issue
Medical devices - Manufacturing defect
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vitros Chemistry Products Versatips | 1039734 | 6801715 |
Issue
|
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 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
| Ortho-Clinical Diagnostics Inc. |
| 100 Indigo Creek Drive, Rochester, New York, United States, 14626 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63782
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