Z-1435-2020 Class II Terminated
FDA device recall Z-1435-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on January 6, 2020 and is designated Class II. Reason for recall: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. The recall status is terminated (terminated July 11, 2022). Affected quantity: 2149.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- January 6, 2020
- Termination Date
- July 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2149
Product Description
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.
Reason for Recall
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
Lot 0010