Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully…
Medical device recall Z-1197-2019. 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
- 559 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 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).
559, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 AC01172 AC01223 AC01265 AC01305 AC01351 AC01046 AC01096 AC01143 AC01173 AC01224 AC01266 AC01306 AC01352 AC01047 AC01097 AC01144 AC01174 AC01225 AC01267 AC01307 AC01353 AC01048 AC01098 AC01145 AC01175 AC01226 AC01268 AC01308 AC01354 AC01049 AC01099 AC01146 AC01176 AC01227 AC01269 AC01309 AC01355 AC01052 AC01100 AC01147 AC01177 AC01229 AC01270 AC01314 AC01359 AC01053 AC01102 AC01148 AC01179 AC01230 AC01271 AC01315 AC01360 AC01055 AC01103 AC01149 AC01180 AC01231 AC01272 AC01316 AC01361 AC01056 AC01106 AC01150 AC01181 AC01232 AC01273 AC01318 AC01362 AC01057 AC01107 AC01151 AC01182 AC01233 AC01274 AC01319 AC01363 AC01058 AC01108 AC01152 AC01183 AC01234 AC01275 AC01320 AC01364 AC01060 AC01109 AC01153 AC01184 AC01236 AC01276 AC01321 AC01365 AC01061 AC01110 AC01154 AC01185 AC01237 AC01277 AC01322 AC01366 AC01062 AC01111 AC01155 AC01186 AC01238 AC01278 AC01323 AC01367 AC01063 AC01112 AC01156 AC01187 AC01239 AC01279 AC01324 AC01368 AC01064 AC01113 AC01157 AC01188 AC01240 AC01280 AC01325 AC01369 AC01065 AC01118…
FDA’s list runs to 5,919 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 5,919 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.