Recall Z-2208-2019— Abbott Ireland Diagnostics Division
Class II · Terminated
Class II FDA medical device recall by Abbott Ireland Diagnostics Division, initiated 2018-11-21, terminated 2021-03-25. It names one FDA 510(k) clearance: K983759. Product: Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.. 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
- 2021-03-25
- Firm location
- Co. Longford, N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
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.