FDA Device recall Z-0666-2019
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 by Abbott Ireland Diagnostics Division, citing 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 n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0666-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-21 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Ireland Diagnostics Division |
| Distribution | AR, FL, GA, MD, OK, VA |
Product
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
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.
Identifiers
| code_info | UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0666-2019%22
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