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Atellica CH 930 Analyzer with Software version: V1.25.1 and… recallZ-0449-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 18, 2021

Open, Classified

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

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

FDA root cause category: Software design

What the company is doing

Siemens issued Urgent Medical Device Correction (UMDC), ASW22-01.A.US, to US customers by FedEx beginning on November 18th, 2021. An Urgent Field Safety Notice (UFSN), ASW22-01.A.OUS, was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021/11/18. Letter states reason for recall, health risk and action to take: The following actions must be taken until your system has been updated to a software version which resolves the issues mentioned in Table 2 above. Siemens Healthineers will notify you when an updated software version is available. Issue 1. TDef Parameters reverting to Default Values When saving changes in the Open Channel configuration screen, saving the screen will reset TDef parameter to default settings. To correct this behavior, navigate back to the TDef screen (Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct (refer to Table 3): x Definition Tab (General) x Definition Tab (Measuring Intervals) x Calculation (General) x Calculation (HIL Alert Indices) x Calculation (Assay Comparison Correlation Factor) x Calibration There is no need to go back to the Open Channel configuration screen after the TDef parameters have been confirmed to be correct or corrected. If navigating back to the Open Channel configuration screen and saving, please repeat above steps. Issue 2. On Board Stability (OBS) Not Updating with Manual Changes Issue 1. TDef Parameters reverting to Default Values When saving changes in the Open Channel configuration screen, saving the screen will reset TDef parameter to default settings. To correct this behavior, navigate back to the TDef screen (Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct (refer to Table 3): x Definition Tab (General) x Definition Tab (Measuring Intervals) x Calculation (General) x Calculation (HIL Alert Indices) x Calc

Recall details

Recall number
Z-0449-2022
Status
Open, Classified
Initiated by the company
Nov 18, 2021
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2,980 units
Product code
JGS
FDA submissions
K151767
Distribution
Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT

Product description

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

Code information (models, lots, serial numbers)

Software version: V1.25.1 and lower. UDI: 00630414002163

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K151767 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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