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Siemens Healthcare Diagnostics, Inc Recall 88792

Description: Atellica IM 1600 Analyzer, SMN 11066000

Siemens Healthcare Diagnostics, Inc Recall 88792 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0125-2022
Event ID88792
Event DescriptionAtellica IM 1600 Analyzer, SMN 11066000
Product TypeDevices
DistributionDomestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
Recall ReasonAncillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Device Classification20211027
Device Code InfoAll units.
Center Classification Date20211016
Recall Initiation Date20210928
Recalling FirmSiemens Healthcare Diagnostics, Inc
Initial Notification Letter
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