Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 0063041
Recalled Product
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: 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.
Hazard / Issue
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Issued by
FDA
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