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Siemens Healthcare Diagnostics, Inc. Recall 89008

Description: Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

Siemens Healthcare Diagnostics, Inc. Recall 89008 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0330-2022
Event ID89008
Event DescriptionDimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
Quantity1407 units
Recall ReasonIncorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Device Classification20211208
Device Code InfoAll software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
Center Classification Date20211202
Recall Initiation Date20211015
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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