Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 3/11/2020
Class II
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.
- Recall Number: Z-1435-2020
REASON
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 1/6/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2149
DISTRIBUTION
US Nationwide and International