FDA Device recall Z-1098-2021
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lith…
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lith… by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1098-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-06 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
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.
Identifiers
| code_info | All Serial Numbers: U18.5093 U18.2418 U18.1099 U18.4188 U18.2819 13002 U18.3698 U18.4498 U18.3629 U18.3056 U…All Serial Numbers: U18.5093 U18.2418 U18.1099 U18.4188 U18.2819 13002 U18.3698 U18.4498 U18.3629 U18.3056 U18.3058 U18.2954 U18.4423 U18.4584 17769 U18.3657 U18.2026 U18.2245 13982 U18.2839 7148 7151 15061 27989 7143 U18.3533 U18.3590 U18.6311 U18.5772 5925 U18.5230 6265 U18.4798 U18.1900 17760 U18.3447 7157 U18.5809 U18.4696 U18.4698 19313 U18.3216 U18.3259 U18.3599 12853 U18.2144 U18.3519 U18.6131 U18.3648 U18.2430 U18.1138 U18.3137 U18.2334 U18.2972 U18.1554 U18.3537 U18.4440 U18.1160 U18.4014 U18.3324 U18.2006 24119 U18.3717 U18.1175 U18.1555 U18.4181 U18.2070 U18.6807 U18.2725 U18.1173 15217 U18.2172 U18.2727 U18.4357 U18.2441 15408 16650 22334 22336 U18.2277 U18.3052 U18.2110 U18.4254 U18.5501 U18.4755 U18.4230 U18.4365 U18.3638 U18.3089 15071 U18.3215 6836 6841 18016 U18.3789 U18.4243 U18.5644 U18.6395 U18.3390 U18.6644 U18.2679 U18.3096 U18.3064 U18.3635 12879 U18.3745 19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.