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Recall Observatory FDA recall evidence

Device product

Atellica IM 1600 Analyzer, SMN 11066000

Z-0125-2022

September 28, 2021

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 88792
Status
Ongoing
Classification
Class II
Quantity
1733
Official record key
device-enforcement:Z-0125-2022

Official wording

Reason: Ancillary 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.

Code information: All units.

Distribution pattern: Domestic 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ancillary 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.