CLASS II ONGOING Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
Atellica IM 1600 Analyzer, SMN recalled
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer, SMN 11066000, distributed in 19 states. The recall was initiated on 28 Sep 2021 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-0125-2022
- FDA event ID
- 88792
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Sep 2021
- FDA classified
- 16 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Sep 2021 | Recall initiated by company | |
| 16 Oct 2021 | Classified by FDA | +18 days |
| 27 Oct 2021 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Product as listed by the FDA
Atellica IM 1600 Analyzer, SMN 11066000
Where it was distributed
Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
ArizonaCaliforniaColoradoGeorgiaKansasMissouriMontanaNorth CarolinaNebraskaNew MexicoNevadaPennsylvaniaTennesseeTexasUtahVirginiaWashingtonWisconsinWyoming
Questions about this recall
Why was it recalled?
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Which lots are affected?
All units.
Where was it sold?
Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. 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 88792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica IM 1300 Analyzer, SMN recalled | Siemens Healthcare Diagnostics | Other | 19 states |
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