Device 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.
Z-1435-2020
Product summary
- Event
- Event 84823
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2149
- Official record key
device-enforcement:Z-1435-2020
Official wording
Reason: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Code information: Lot 0010
Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.
Derived failure modes
-
Device software or design
software error