Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully…
Medical device recall Z-1196-2019. Published in FDA’s Enforcement Report on Apr 24, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 24, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 1097 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1097, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 AI01265 AI01307 AI01351 AI01391 AI01071 AI01123 AI01166 AI01201 AI01266 AI01308 AI01352 AI01392 Ai01072 AI01124 AI01167 AI01203 AI01267 AI01309 AI01353 AI01393 AI01073 AI01125 AI01168 AI01204 AI01268 AI01310 AI01354 AI01394 AI01074 AI01126 AI01169 AI01205 AI01269 AI01311 AI01355 AI01395 AI01075 AI01127 AI01170 AI01206 AI01270 AI01312 AI01356 AI01396 AI01079 AI01128 AI01171 AI01207 AI01271 AI01313 AI01357 AI01397 AI01081 AI01129 AI01172 AI01208 AI01272 AI01314 AI01358 AI01398 AI01082 AI01130 AI01173 AI01209 AI01274 Ai01315 AI01359 AI01399 AI01083 AI01131 AI01174 AI01210 AI01275 AI01316 AI01360 AI01400 AI01084 Ai01132 AI01175 AI01211 AI01276 AI01317 AI01361 AI01401 Ai01085 AI01133 AI01176 AI01212 AI01277 AI01319 AI01362 AI01402 AI01086 AI01136 AI01177 AI01213 AI01279 AI01320 AI01363 AI01403 AI01087 AI01137 AI01178 AI01214 AI01280 AI01321 AI01364 AI01404 AI01088 AI01138 AI01179 AI01216 AI01281 Ai01322 AI01365 AI01405 AI01089 AI01139 AI01180 AI01217 AI01282 AI01323 AI01366 AI01406 AI01090 AI01140…
FDA’s list runs to 11,583 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide in the states of AR, CA, GA, ME, MN, MO, NY, OK, SC, TN, TX, UT, and VA, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, and VIETNAM.
The states and territories these words name
13 states and territories.
Every one of them
- Arkansas
- California
- Georgia
- Maine
- Minnesota
- Missouri
- New York
- Oklahoma
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 26, 2019.
- FDA classified it on Apr 18, 2019.
- FDA’s Enforcement Report published it on Apr 24, 2019.
- FDA terminated it on Sep 28, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Gmbh & Co. KG, of Wiesbaden, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 11,583 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.