# FDA recall Z-2770-2020

> **Ortho Clinical Diagnostics** · Class II · device recall initiated 2020-07-17.

## Product

VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

## Reason for recall

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

## Distribution

Worldwide distribution - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2770-2020
- **Recalling firm:** Ortho Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-17
- **Report date:** 2020-08-19
- **Termination date:** 2021-07-16

- **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-2770-2020

## Citation

> AI Analytics. FDA recall Z-2770-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2770-2020. Source: US FDA. Licensed CC0.

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