# FDA recall Z-0735-2022

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2021-12-10.

## 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.

## Distribution

Domestic distribution nationwide. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-0735-2022
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-10
- **Report date:** 2022-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2022

## Citation

> AI Analytics. FDA recall Z-0735-2022. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0735-2022. Source: US FDA. Licensed CC0.

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