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Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage:
Recalled March 11, 2020 · FDA recall Z-1435-2020 · Siemens Healthcare Diagnostics
Hazard
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. · FDA Class II
Units
2149
Sold at
Domestic distribution nationwide. Foreign distribution worldwide.
Description
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →