Siemens Healthcare Diagnostics, Inc.: 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 clin

Is my product affected?

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

• UPC 00630414002163

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics has recalled the Atellica CH 930 Analyzer with software version V1.25.1 and lower, an automated clinical chemistry analyzer used to perform diagnostic tests. The recall affects approximately 2,980 units distributed nationwide and internationally. The device has two software-related issues: test definition parameters for open channel assays may revert to default values, which could shift test results by the magnitude of the implemented assay correlation factor, and on-board stability settings may not update when manually changed for open channel assays, potentially allowing continued use of reagents past their expiration date.

Both issues could result in erroneous patient sample results. The recall applies to devices with software version V1.25.1 and lower, identified by UDI 00630414002163. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

(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

Details from the source

Reason for recall: (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 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 Quantity: 2,980 units Lot/code info: Software version: V1.25.1 and lower. UDI: 00630414002163

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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