Alinity recallZ-0669-2019 · Abbott Ireland Diagnostics Division · initiated Nov 21, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Ireland Diagnostics Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0669-2019
- Status
- Terminated
- Initiated by the company
- Nov 21, 2018
- Recalling firm
- Abbott Ireland Diagnostics Division
- Quantity
- 760 units
- Product code
- MRG
- FDA submissions
- K153375
- Distribution
- AR, FL, GA, MD, OK, VA
Product description
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Code information (models, lots, serial numbers)
UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity 08P4532Abbott Ireland · SYSTEM, TEST, VITAMIN D1 recall3 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81632).
- Z-0664-2019 · TerminatedAlinity i TSH Reagent Kit, List Number 07P4830
- Z-0665-2019 · TerminatedAlinity i Free T4 Reagent Kit, List Number 07P7030
- Z-0666-2019 · TerminatedAlinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- Z-0667-2019 · TerminatedAlinity i Estradiol Reagent Kit, List Number 07P5020
- Z-0668-2019 · TerminatedAlinity i Progesterone Reagent Kit, List Number 08P3620
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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