FDA Device recall Z-0613-2024
Alinity ci-series System Control Module, REF: 03R70-01
- FDA Device
- Class II
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Alinity ci-series System Control Module, REF: 03R70-01 by Abbott Laboratories, citing there are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0613-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-30 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
Alinity ci-series System Control Module, REF: 03R70-01
Reason
There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
Identifiers
| code_info | UDI-DI: 00380740137410. Software Version 3.4.0 and lower. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0613-2024%22
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