Class II — Roche Diagnostics Operations, Inc.
| Recalling firm | Roche Diagnostics Operations Inc. |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 1,214 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-01-06 |
| Classified | 2021-02-08 |
| Terminated | 2024-02-28 |
| Recall number | Z-1098-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Roche Diagnostics Operations, Inc. (Z-1098-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87102/
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