# FDA recall Z-1311-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-12-22.

## Product

Elecsys BRAHMS PCT    Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).

## Reason for recall

Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

## Distribution

US Distribution in states of: CA, FL and IN.

## Key facts

- **Recall number:** Z-1311-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-22
- **Report date:** 2018-04-11
- **Termination date:** 2019-04-05

- **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-1311-2018

## Citation

> AI Analytics. FDA recall Z-1311-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1311-2018. Source: US FDA. Licensed CC0.

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