Reported Dec 6, 2023 · Ongoing
RAPIDPOINT 500e Blood Gas System
Siemens Healthcare Diagnostics 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: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- RAPIDPOINT 500e Blood Gas System
- Lot codes and dates
Material No. 114167511141675211416754& 11416755
- UDI-DI
006304142861500063041428616700630414286174& 00630414286143All Units and Software Versions
- Amount recalled
- 8,749 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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