FDA-Device2020-03-11Class II
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
Siemens Healthcare Diagnostics, Inc.
Hazard
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
2149
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1435-2020Don't want to check this manually?
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