CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
Alinity c Iron Reagent, Reference Number 08P3920 recalled
Sentinel CH SpA is recalling Alinity c Iron Reagent, Reference Number 08P3920, distributed nationwide in the US. The recall was initiated on 29 Sep 2023 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-0326-2024
- FDA event ID
- 93298
- Recalling firm
- Sentinel CH SpA, Milan, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2023
- FDA classified
- 17 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Sep 2023 | Recall initiated by company | |
| 17 Nov 2023 | Classified by FDA | +49 days |
| 29 Nov 2023 | 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
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
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
Alinity c Iron Reagent, Reference Number 08P3920
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Alinity c Iron Reagent, Reference Number 08P3920 recalled?
Yes. Sentinel CH SpA recalled Alinity c Iron Reagent, Reference Number 08P3920 on 29 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0326-2024.
Why was it recalled?
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
Which lots are affected?
UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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