FDA Device recall Z-1197-2019
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer all…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer all… 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-1197-2019 |
| 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 c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
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 | AC01016 AC01075 AC01127 AC01157 AC01208 AC01250 AC01290 AC01336 AC01018 AC01076 AC01128 AC01158 AC01209 AC01251 AC0129…AC01016 AC01075 AC01127 AC01157 AC01208 AC01250 AC01290 AC01336 AC01018 AC01076 AC01128 AC01158 AC01209 AC01251 AC01291 AC01337 AC01019 AC01077 AC01129 AC01159 AC01210 AC01252 AC01292 AC01338 AC01031 AC01079 AC01130 AC01160 AC01211 AC01253 AC01293 AC01339 AC01032 AC01080 AC01131 AC01161 AC01212 AC01254 AC01294 AC01340 AC01033 AC01085 AC01132 AC01162 AC01213 AC01255 AC01295 AC01341 AC01034 AC01086 AC01133 AC01163 AC01214 AC01256 AC01296 AC01342 AC01035 AC01087 AC01134 AC01164 AC01215 AC01257 AC01297 AC01343 AC01036 AC01088 AC01135 AC01165 AC01216 AC01258 AC01298 AC01344 AC01037 AC01089 AC01136 AC01166 AC01217 AC01259 AC01299 AC01345 AC01038 AC01090 AC01137 AC01167 AC01218 AC01260 AC01300 AC01346 AC01039 AC01091 AC01138 AC01168 AC01219 AC01261 AC01301 AC01347 AC01040 AC01092 AC01139 AC01169 AC01220 AC01262 AC01302 AC01348 AC01041 AC01093 AC01140 AC01170 AC01221 AC01263 AC01303 AC01349 AC01042 AC01094 AC01141 Ac01171 AC01222 AC01264 AC01304 AC01350 AC01045 AC01095 AC01142 A |
|---|
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-1197-2019%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.