epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX)
Summary
The FDA issued a Class II for epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 114 by Siemens Healthcare Diagnostics Inc. Reason: Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous.
Details
Source
Device Recall
External ID
Z-0601-2024
Action Date
2023-12-27
Status
Ongoing
Category
device
Product Description
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Lot/Code Info: UDI-DI: 00630414605760 00630414606095 00630414605821 00630414605838 00630414605678 00630414605814 00630414612447 00630414631028; All serial numbers.
Quantity Affected: 10,183 devices
Reason for Recall
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-19
Company
Norwood, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics Inc have FDA actions?
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0601-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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