FDAFDA · Food and drugs·Recall number Z-1435-2020
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.
Published March 11, 2020 · Recall initiated: January 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot
- Lot 0010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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