Product Safety Recalls

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Siemens Healthcare Diagnostics, Inc. Recall 89160

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

Siemens Healthcare Diagnostics, Inc. Recall 89160 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0449-2022
Event ID89160
Event DescriptionAtellica 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
Product TypeDevices
DistributionNationwide 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
Quantity2,980 units
Recall Reason(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
Device Classification20220112
Device Code InfoSoftware version: V1.25.1 and lower. UDI: 00630414002163
Center Classification Date20220103
Recall Initiation Date20211118
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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