Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage…

Recall date

January 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1435-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Why it was recalled

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.