CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report
Alinity i Progesterone Reagent Kit, List Number 08P3620 recalled
Abbott Ireland Diagnostics Division is recalling Alinity i Progesterone Reagent Kit, List Number 08P3620, distributed in Arkansas, Florida, Georgia, Maryland, Oklahoma, Virginia. The recall was initiated on 21 Nov 2018 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-0668-2019
- FDA event ID
- 81632
- Recalling firm
- Abbott Ireland Diagnostics Division, Co. Longford
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2018
- FDA classified
- 22 Dec 2018
- Reported
- 2 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Nov 2018 | Recall initiated by company | |
| 22 Dec 2018 | Classified by FDA | +31 days |
| 2 Jan 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Alinity i Progesterone Reagent Kit, List Number 08P3620
Where it was distributed
AR, FL, GA, MD, OK, VA
Questions about this recall
Why was it recalled?
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Which lots are affected?
UDI/Lot Numbers (01)00380740121877 (17)190503(10) 91254UI00 / 91254UI00 (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00
Where was it sold?
AR, FL, GA, MD, OK, VA
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.
Other products in this recall event
5 other products · FDA event 81632More recalls from Abbott Ireland Diagnostics Division
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity i Ferritin Reagent Kit recalled by Abbott Ireland Diagnostics | Abbott Ireland Diagnostics Division | Potency & Assay | 6 states |
| Device | CLASS II | Abbott Alinity i Estradiol Reagent Kit recalled | Abbott Ireland Diagnostics Division | Potency & Assay | Nationwide |
| Device | CLASS II | Abbott Architect Estradiol Reagent Kit recalled | Abbott Ireland Diagnostics Division | Potency & Assay | Nationwide |
| Device | CLASS II | Architect Total T3 Reagent Kit used on Architect i1000SR recalled | Abbott Ireland Diagnostics Division | Potency & Assay | Nationwide |
| Device | CLASS II | Architect Free T3 Reagent Kit used on Architect i1000SR recalled | Abbott Ireland Diagnostics Division | Potency & Assay | Nationwide |
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