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.
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.
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.
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.
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.
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.
Look for the serial number on your device, which is listed in the recall record.
The device may display calcium results with the wrong arrow direction when set to mg/dL, potentially leading to misinterpreted results and incorrect medical decisions.
The recall record does not mention a remedy or fix.
Check the serial number on your device against the list of affected serial numbers provided in the recall record.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1098-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1098-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
