CLASS III ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report
Alinity i Anti-TPO Reagent Kit, List Number 09P3521 recalled
Abbott Irel is recalling Alinity i Anti-TPO Reagent Kit, List Number 09P3521, distributed nationwide in the US. The recall was initiated on 24 Apr 2023 and the FDA has classified it as Class III.
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-1696-2023
- FDA event ID
- 92271
- Recalling firm
- Abbott Irel, Sligo
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Apr 2023
- FDA classified
- 8 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Apr 2023 | Recall initiated by company | |
| 8 Jun 2023 | Classified by FDA | +45 days |
| 14 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Product as listed by the FDA
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Where it was distributed
US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
Nationwide CaliforniaColoradoFloridaGeorgiaIllinoisKentuckyLouisianaMarylandMichiganMinnesotaNew JerseyNew YorkOhioRhode IslandSouth CarolinaSouth DakotaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Which lots are affected?
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Where was it sold?
US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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