Reported Jan 2, 2019 · Terminated
Alinity i Estradiol Reagent Kit, List Number 07P5020
Abbott Ireland Diagnostics Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Ireland Diagnostics Division · Lisnamuck · Co. Longford · N/A
Is this the product you have?
- Alinity i Estradiol Reagent Kit, List Number 07P5020
- Lot codes and dates
- UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00
- Amount recalled
- 79 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Abbott Ireland Diagnostics Division recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.