Z-1436-2020Class II

Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower -

Name: Z-1436-2020 Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-01-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-01-06 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2020-01-06. FDA classified it as Class II and gives the reason as "A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1436-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Posted: 2020-03-04
Terminated: 2022-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: N/A
Reason for recall: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: 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.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: Lot 0010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1436-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1435-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04
Z-1436-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)