# FDA recall Z-1675-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2021-04-26.

## Product

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

## Reason for recall

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

## Distribution

US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-1675-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-26
- **Report date:** 2021-06-02

- **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-1675-2021

## Citation

> AI Analytics. FDA recall Z-1675-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1675-2021. Source: US FDA. Licensed CC0.

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