Z-0735-2022 Class II Ongoing
FDA device recall Z-0735-2022 was initiated by Ortho-Clinical Diagnostics, Inc. on December 10, 2021 and is designated Class II. Reason for recall: 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, … The recall status is ongoing. Affected quantity: 4125 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- December 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4125 units
Product Description
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Canada.
Code Information
UDI 10758750006786 Lot 1039734