# FDA recall Z-1688-2021

> **Ortho-Clinical Diagnostics, INc.** · Class II · device recall initiated 2021-05-03.

## Product

VITROS CoV2 Ag calibrator  (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

## Reason for recall

Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France.

## Key facts

- **Recall number:** Z-1688-2021
- **Recalling firm:** Ortho-Clinical Diagnostics, INc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-03
- **Report date:** 2021-06-02
- **Termination date:** 2023-10-24

- **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-1688-2021

## Citation

> AI Analytics. FDA recall Z-1688-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1688-2021. Source: US FDA. Licensed CC0.

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