Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI 10758750006786 Lot 1039734
Products Sold
UDI 10758750006786 Lot 1039734
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 due to 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 dete. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026