Ortho-Clinical Diagnostics, Inc. 2022-03-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0735-2022
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is… Recall
Issued March 16, 2022 · Ortho-Clinical Diagnostics, Inc.
In March 2022, Ortho-Clinical Diagnostics, Inc. recalled the VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
What you should do
- 1 Stop using VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ortho-Clinical Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ortho-Clinical Diagnostics, Inc.
- Category
- Health
- Recall date
- March 16, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution nationwide. Foreign distribution to Canada.
- Recall number
- FDA-Z-0735-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Ortho-Clinical Diagnostics, Inc. has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.