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epoc NXS Host Blood Analysis System, Siemens Material… recallZ-0601-2024 · Siemens Healthcare Diagnostics Inc · initiated Oct 19, 2023

Class II Open, Classified All recalls posted in December 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

An Urgent Medical Device Correction notification letter dated October 2023 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. To mitigate this issue, follow the instructions below to set Delete Blood Test settings to NEVER and continue using device as normal. To change the device setting: 1. Log in as Administrator 2. Select Settings 3. Select General Settings 4. In the General Settings, scroll to the bottom and select Delete Blood Tests 5. Set Delete Blood Tests to Never. If a Data Manager is in use, the Delete Blood Tests option must be changed on the Data Manager. Do NOT make the change on the epoc Host as the setting will be overwritten on the next synchronization. The Delete Blood Tests option may have a different name depending on the Data Manager in use. Please contact the Data Manager customer service for additional support, if needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you are a distributor, please ensure your customers receive this UMDC letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. This issue will be corrected with the next NXS software version (4.12.XX) which must be installed by December 12, 2023, when current software version (4.11.11) expires. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recall details

Recall number
Z-0601-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 19, 2023
Posted by the FDA
Dec 21, 2023
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
10,183 devices
Product code
CHL
FDA submissions
K200107
Distribution
US Nationwide. Global Distribution.

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

Code information (models, lots, serial numbers)

UDI-DI: 00630414605760 00630414606095 00630414605821 00630414605838 00630414605678 00630414605814 00630414612447 00630414631028; All serial numbers.

Other devices under the same FDA submission

1 device cleared under K200107 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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