Siemens Healthcare Diagnostics, Inc.: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

Agency Publication Date: March 4, 2020

Affected Products

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.

Lot 0010

Lot Numbers:

0010

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.

Lot 0010

Lot Numbers:

0010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84823

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Manufactured In: United States

Units Affected: 2149

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot 0010

Lot Numbers:

0010

Lot 0010

Lot Numbers:

0010