CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Advia Centaur aTPO Assay, Material Number recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test), distributed nationwide in the US. The recall was initiated on 21 Aug 2024 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-3304-2024
- FDA event ID
- 95259
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2024
- FDA classified
- 27 Sep 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Aug 2024 | Recall initiated by company | |
| 27 Sep 2024 | Classified by FDA | +37 days |
| 9 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
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
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Which lots are affected?
UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
Where was it sold?
Worldwide distribution - US Nationwide.
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 95259This product is part of a recall event; the main page for the event is Atellica IM aTPO Assay, Material Number recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica IM aTPO Assay, Material Number recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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