CLASS II Device recall · Reported 10 Nov 2021 · FDA Enforcement Report
Atellica IM Sars-CoV-2 Antigen Assay (100 Test Kit), SMN # recalled
Siemens Healthcare Diagnostics is recalling Atellica IM Sars-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861, distributed nationwide in the US. The recall was initiated on 22 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-0195-2022
- FDA event ID
- 88768
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2021
- FDA classified
- 3 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Sep 2021 | Recall initiated by company | |
| 3 Nov 2021 | Classified by FDA | +42 days |
| 10 Nov 2021 | 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
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Where it was distributed
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Nationwide AlaskaCaliforniaColoradoDistrict of ColumbiaGeorgiaIllinoisMaineNorth CarolinaNevadaNew YorkOregonPennsylvaniaPuerto RicoVirginia
Questions about this recall
Why was it recalled?
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Which lots are affected?
Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.
Where was it sold?
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
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 88768This product is part of a recall event; the main page for the event is Advia Centaur Sars-CoV-2 Antigen Assay (100 Test Kit) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Centaur Sars-CoV-2 Antigen Assay (100 Test Kit) recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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