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Siemens Healthcare Diagnostics, Inc recalls Atellica IM 1300 Analyzer, SMN 11066001
Recalled October 27, 2021 · FDA recall Z-0124-2022 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
1193
Sold at
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.
Description
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.
Product
Atellica IM 1300 Analyzer, SMN 11066001
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →