Roche 9180 Electrolyte Analyzer Recalled for Incorrect Calcium Display Arrows
Roche Diagnostics is recalling 1,214 units of the 9180 Electrolyte Analyzer because the device may display incorrect arrow directions for ionized calcium results when configured in mg/dL, potentially leading to misinterpretation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of incorrect medical decision-making due to misinterpretation of diagnostic results, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 1,214 units of the 9180 Electrolyte Analyzer, catalog number 03157334001. The device is intended for in vitro diagnostic use to measure sodium, potassium, chloride, ionized calcium, and lithium in various biological samples. The units were distributed nationwide in the United States.
The recall is due to a software defect that may cause the device to display an incorrect arrow direction for ionized calcium (iCa++) results. Specifically, if the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and the measured value is lower than the normal range, the device displays an upward arrow instead of a downward arrow. The numeric result is displayed correctly, but the arrow warning reflects the normal ranges for mmol/L rather than the selected mg/dL unit. This discrepancy may lead to misinterpretation of results and incorrect medical decisions.
Healthcare facilities and laboratories should check their inventory for the affected serial numbers listed in the recall notice. Users should contact Roche Diagnostics for instructions on how to resolve the issue or replace the affected units.
The recalled product
- 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.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 1,214
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · misinterpretation
See all →- HighNatus SD LTM 64 PLUS EEG recorders may shift traces one second
FDA (Devices) · 2026-06-17
- HighMindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies
FDA (Devices) · 2018-10-24
- HighSiemens Gentamicin Reagent Cartridge Recall Due to Low-End Inaccuracy
FDA (Devices) · 2018-06-20
- HighInvivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display
FDA (Devices) · 2018-04-11
- HighPhilips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
FDA (Devices) · 2016-02-10