Siemens Healthcare Diagnostics, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot 0010
Products Sold
Lot 0010
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lo due to A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Recommended Action
Per FDA guidance
On January 7, 2020, the firm issued an Urgent Medical Device Correction letter to all affected US customers. Customers were informed that the analyzer may erroneously identify that humidity packs Lot 0100 have expired and eject them. The firm is investigating the root cause and customers will be notified when additional information is available. The behavior will be corrected in a new version of software that will be available shortly. It is important to note that Humidity Packs do have an onboard stability (OBS) of 180 days that is monitored by the system software. Once loaded onto an analyzer, the OBS of each pack is monitored. The firm is not recommending a review of previously generated results, since the accuracy of results is not affected by this issue. Customers were given workaround instructions so that they may manually enter the humidity packs.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026