FDA Device recall Z-1196-2019
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer a…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer a… by Abbott And Kg, citing the safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1196-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-26 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
Product
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Reason
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
Identifiers
| code_info | AI01015 AI01100 AI01149 AI01180 AI01246 AI01292 AI01335 AI01376 AI01020 AI01101 AI01150 AI01181 AI01249 AI01293 AI01336…AI01015 AI01100 AI01149 AI01180 AI01246 AI01292 AI01335 AI01376 AI01020 AI01101 AI01150 AI01181 AI01249 AI01293 AI01336 AI01377 AI01025 AI01102 AI01151 Ai01182 AI01252 AI01294 AI01337 AI01378 AI01027 AI01103 AI01152 AI01183 AI01253 AI01295 AI01338 AI01379 AI01032 AI01104 AI01153 AI01184 AI01254 AI01296 AI01339 AI01380 AI01036 AI01105 AI01154 AI01185 AI01255 AI01297 AI01340 AI01381 AI01054 AI01109 AI01155 AI01187 AI01256 AI01298 AI01341 AI01382 AI01055 AI01110 AI01156 AI01188 AI01257 AI01299 AI01343 AI01383 AI01056 AI01111 AI01157 AI01189 AI01258 AI01300 AI01344 AI01384 AI01057 AI01112 AI01158 AI01190 AI01259 AI01301 AI01345 AI01385 AI01061 AI01114 AI01159 AI01193 AI01260 AI01302 AI01346 AI01386 AI01064 AI01115 AI01160 Ai01194 AI01261 AI01303 AI01347 AI01387 AI01065 AI01116 AI01161 AI01196 AI01262 AI01304 AI01348 AI01388 AI01066 Ai01117 Ai01162 AI01197 AI01263 AI01305 AI01349 AI01389 AI01068 AI01120 AI01164 AI01198 AI01264 AI01306 AI01350 AI01390 AI01069 AI01122 AI01165 AI01200 AI0 |
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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-1196-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.