# FDA recall Z-1519-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2018-01-02.

## Product

Roche Acetaminophen assay  03255379160-HAcetaminophen (P)  20767174160- cobas c Integra AAcetaminophen150 test

## Reason for recall

The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400  plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following  statement in the Limitations-interference section:  "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause  unreliable results."

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-1519-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-02
- **Report date:** 2018-05-02
- **Termination date:** 2019-04-25

- **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-1519-2018

## Citation

> AI Analytics. FDA recall Z-1519-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1519-2018. Source: US FDA. Licensed CC0.

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