# FDA recall Z-2182-2018

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

## Product

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay.  Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and  17312BB.

## 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. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].

## 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-2182-2018
- **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-2182-2018

## Citation

> AI Analytics. FDA recall Z-2182-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2182-2018. Source: US FDA. Licensed CC0.

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