Recall Z-0667-2019
Abbott Ireland Diagnostics Division · initiated November 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alinity i Estradiol Reagent Kit, List Number 07P5020
Codes / lots: UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced.
Details
- Recall number
- Z-0667-2019
- Initiated
- November 21, 2018
- Terminated
- April 1, 2021
- Product code
- CHP – Radioimmunoassay, Estradiol
- Quantity
- 79 units
- Distribution
- AR, FL, GA, MD, OK, VA
- Recalling firm
- Abbott Ireland Diagnostics Division, Lisnamuck Co. Longford
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0664-2019 Class II | Alinity i TSH Reagent Kit, List Number 07P4830Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0665-2019 Class II | Alinity i Free T4 Reagent Kit, List Number 07P7030Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0666-2019 Class II | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0668-2019 Class II | Alinity i Progesterone Reagent Kit, List Number 08P3620Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0669-2019 Class II | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |