9180 Electrolyte Analyzer — Class II medical device recall Z-1098-2021
Terminated recall by Roche Diagnostics Operations, Inc., reported 2021-02-17, distributed nationwide. May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of re
| Recall number | Z-1098-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2021-01-06 |
| Classified | 2021-02-08 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,214 units |
| Serial numbers | 12354, 12365, 12366, 12367, 12369, 12370, 12374, 12375, 12405, 12416, 12495, 12547, 12563, 12564, 12571, 12584, 12603, 12604, 12605, 12680, 12683, 12684, 12728, 12785, 12786 and 475 more |
| Model numbers | 03157334001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1098-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.