FDA Device recall Z-0735-2022
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box by Ortho Clinical Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0735-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-10 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
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.
Identifiers
| code_info | UDI 10758750006786 Lot 1039734 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2022%22
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