VITROS Chemistry Products VersaTips — Class II medical device recall Z-0735-2022
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2022-03-16, distributed nationwide. The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispens
| Recall number | Z-0735-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2021-12-10 |
| Classified | 2022-03-08 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,125 units |
| UPC / GTIN / UDI-DI | 10758750006786 |
| Lot numbers | 1039734 |
| Model numbers | 6801715A |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0735-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.