Recall Z-0667-2019— Abbott Ireland Diagnostics Division
Class II · Terminated
Class II FDA medical device recall by Abbott Ireland Diagnostics Division, initiated 2018-11-21, terminated 2021-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity i Estradiol Reagent Kit, List Number 07P5020. Reason: 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..
- Recalling firm
- Abbott Ireland Diagnostics Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-21
- Terminated
- 2021-04-01
- Firm location
- Co. Longford, Ireland
Product description
Alinity i Estradiol Reagent Kit, List Number 07P5020
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.