CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
Atellica IM Humidity Pack (Qty , SMN recalled
Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Pack (Qty , SMN 11313496, distributed nationwide in the US. The recall was initiated on 6 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1436-2020
- FDA event ID
- 84823
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2020
- FDA classified
- 4 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Jan 2020 | Recall initiated by company | |
| 4 Mar 2020 | Classified by FDA | +58 days |
| 11 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Domestic distribution nationwide. Foreign distribution worldwide.
Questions about this recall
Why was it recalled?
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Which lots are affected?
Lot 0010
Where was it sold?
Domestic distribution nationwide. Foreign distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84823This product is part of a recall event; the main page for the event is Atellica IM Humidity Pack (Qty , SMN recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica IM Humidity Pack (Qty , SMN recalled | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide |
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