Roche 9180 Electrolyte Analyzer May Show Wrong Calcium Arrow Direction
Roche recalls 9180 Electrolyte Analyzer units with serial numbers listed in the record. The device may display calcium results with incorrect arrow direction, potentially leading to misinterpreted results and incorrect medical decisions.
Lower-risk 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.
Contact the company
What happened, in plain English
Roche is recalling specific models of their 9180 Electrolyte Analyzer due to a display error that may show calcium results with the wrong arrow direction. This could lead to misinterpreted results and incorrect medical decisions if the unit is set to display results in mg/dL instead of mmol/L. Read more at govinfonow.com/recall/63464-roche-9180-electrolyte-analyzer-may-show-wrong-calcium-arrow-direction.
Source Summary by GovInfoNow · govinfonow.com/recall/63464-roche-9180-electrolyte-analyzer-may-show-wrong-calcium-arrow-direction · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1098-2021
Cite this page
“Roche 9180 Electrolyte Analyzer May Show Wrong Calcium Arrow Direction.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63464-roche-9180-electrolyte-analyzer-may-show-wrong-calcium-arrow-direction. Based on FDA recall #Z-1098-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2021%22&limit=1).
Why it’s dangerous
The device may display calcium results with an upward arrow instead of a downward arrow when the unit is set to show results in mg/dL. This error occurs because the display uses mmol/L ranges by default, but shows warnings based on mg/dL values incorrectly. The numeric result itself is correct, but the arrow direction may lead to misinterpretation of results.
Who’s affected
Healthcare facilities and individuals using the 9180 Electrolyte Analyzer for blood tests. Those who have the specific serial numbers listed in the recall record are most at risk.
How to tell if you have this one
Check the serial number on your 9180 Electrolyte Analyzer. The affected units have serial numbers listed in the recall record, which include many numbers starting with 'U18.' and other specific codes.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on your device, which is listed in the recall record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1098-2021 (January 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1098-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.