FDA Device recall Z-2401-2020
Alinity C, Processing Module
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Alinity C, Processing Module by Abbott And Kg, citing there is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2401-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-12 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, PR, SC, SD, TN, TX, UT, VA, WI |
Product
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Reason
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Identifiers
| code_info | List Number: 03R67-01: All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2020%22
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