Reported Feb 17, 2021 · Terminated
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride,…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- 9180
- Electrolyte Analyzer - Product Usageintended 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
- Lot codes and dates
- All Serial Numbers
1,214 of 1,214 codes
U18.5093U18.2418U18.1099U18.4188U18.281913002U18.3698U18.4498U18.3629U18.3056U18.3058U18.2954U18.4423U18.458417769U18.3657U18.2026U18.224513982U18.28397148715115061279897143U18.3533U18.3590U18.6311U18.57725925U18.52306265U18.4798U18.190017760U18.34477157U18.5809U18.4696U18.469819313U18.3216U18.3259U18.359912853U18.2144U18.3519U18.6131U18.3648U18.2430U18.1138U18.3137U18.2334U18.2972U18.1554U18.3537U18.4440U18.1160U18.4014U18.3324
- All Serial Numbers
- Amount recalled
- 1,214 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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