# FDA recall Z-1444-2020

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2020-02-07.

## Product

Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer

## Reason for recall

The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.

## Key facts

- **Recall number:** Z-1444-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-07
- **Report date:** 2020-03-11
- **Termination date:** 2024-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2020

## Citation

> AI Analytics. FDA recall Z-1444-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1444-2020. Source: US FDA. Licensed CC0.

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