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Recall Observatory FDA recall evidence

Device product

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Z-0735-2022

December 10, 2021

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 89362
Status
Ongoing
Classification
Class II
Quantity
4125 units
Official record key
device-enforcement:Z-0735-2022

Official wording

Reason: 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.

Code information: UDI 10758750006786 Lot 1039734

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.