CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Atellica IM CA 19-9 (250 Test recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 (250 Test, distributed nationwide in the US. The recall was initiated on 26 Jul 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-3102-2024
- FDA event ID
- 95118
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jul 2024
- FDA classified
- 11 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jul 2024 | Recall initiated by company | |
| 11 Sep 2024 | Classified by FDA | +47 days |
| 18 Sep 2024 | 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
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
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 CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239
Where it was distributed
Worldwide - US Nationwide distribution
Questions about this recall
Why was it recalled?
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
Which lots are affected?
UDI-DI: (01)00630414293516(10)56434535(17)20240914 Kit Lot: 56434535
Where was it sold?
Worldwide - US Nationwide distribution
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
4 other products · FDA event 95118This product is part of a recall event; the main page for the event is Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Advia Centaur CA 19-9 (50 Test)-In vitro diagnostic use recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Advia Centaur CA 19-9 (250 Test)-In vitro diagnostic use recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |