# FDA recall Z-2181-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-04-19.

## Product

Dimension Gentamicin Flex reagent cartridge, DM GENT,  gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.

## Reason for recall

The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.

## Distribution

Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.

## Key facts

- **Recall number:** Z-2181-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-19
- **Report date:** 2018-06-20
- **Termination date:** 2020-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2018

## Citation

> AI Analytics. FDA recall Z-2181-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2181-2018. Source: US FDA. Licensed CC0.

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