# FDA recall Z-1098-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2021-01-06.

## Product

9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials.  catalog number 03157334001 .  in vitro diagnostic use.

## Reason for recall

May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1098-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-06
- **Report date:** 2021-02-17
- **Termination date:** 2024-02-28

- **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-1098-2021

## Citation

> AI Analytics. FDA recall Z-1098-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1098-2021. Source: US FDA. Licensed CC0.

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