Class 2 Device Recall Abbott Alinity c

• Date Initiated by Firm: February 26, 2019
• Create Date: April 18, 2019
• Recall Status: Terminated on September 28, 2022
• Recall Number: Z-1197-2019
• Recall Event ID: 82511
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• 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).
• Code Information: 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 AC01158 AC01189 AC01241 AC01281 AC01326 AC01370 AC01066 AC01119 AC01159 AC01190 AC01242 AC01282 AC01327 AC01372 AC01067 AC01120 AC01160 AC01191 AC01243 AC01283 AC01328 AC01373 AC01068 AC01121 AC01161 AC01192 AC01244 AC01284 AC01329 AC01374 AC01069 AC01122 AC01162 AC01193 AC01245 AC01285 AC01330 AC01375 AC01071 AC01123 AC01163 AC01194 AC01246 AC01286 AC01332 AC01376 AC01072 AC01124 AC01164 AC01195 AC01247 AC01287 AC01333 AC01377 AC01073 AC01125 AC01165 AC01196 AC01248 AC01288 AC01334 AC01378 AC01074 AC01126 AC01166 AC01197 AC01249 AC01289 AC01335 AC01379 AC01381 AC01425 AC01467 AC01512 AC01565 AC01655 AC01382 AC01426 AC01468 AC01513 AC01567 AC01656 AC01383 AC01427 AC01469 AC01514 AC01568 AC01657 AC01384 AC01428 AC01470 AC01515 AC01569 AC01658 AC01385 AC01429 AC01471 AC01516 AC01570 AC01659 AC01386 AC01430 AC01472 AC01517 AC01571 AC01660 AC01388 AC01433 AC01473 AC01518 AC01572 AC01661 AC01389 AC01434 AC01474 AC01519 AC01574 AC01662 AC01390 AC01435 AC01475 AC01521 AC01575 AC01663 AC01391 AC01436 AC01476 AC01522 AC01576 AC01666 AC01392 AC01437 AC01477 AC01523 AC01577 AC01670 AC01393 AC01438 AC01478 AC01524 AC01578 AC01692 AC01394 AC01439 AC01479 AC01527 AC01579 AC01694 AC01395 AC01440 AC01480 AC01528 AC01580 AC01695 AC01396 AC01441 AC01481 AC01529 AC01583 AC01705 AC01397 AC01442 AC01482 AC01531 AC01584 AC01706 AC01398 AC01443 AC01483 AC01532 AC01585 AC01707 AC01399 AC01444 AC01484 AC01533 AC01593 AC01708 AC01401 AC01445 AC01485 AC01534 AC01594 AC01709 AC01403 AC01446 AC01487 AC01536 AC01596 AC01710 AC01404 AC01447 AC01488 AC01539 AC01597 AC01711 AC01405 AC01448 AC01489 AC01540 AC01598 AC01712 AC01406 AC01449 AC01490 AC01541 AC01600 AC01713 AC01407 AC01450 AC01491 AC01542 AC01601 AC01728 AC01408 AC01451 AC01496 AC01543 AC01611 AC01729 AC01409 AC01452 AC01497 AC01544 AC01612 AC01735 AC01410 AC01453 AC01498 AC01546 AC01613 AC01736 AC01411 AC01454 AC01499 AC01547 AC01614 AC01737 AC01412 AC01455 AC01500 AC01550 AC01616 AC01738 AC01413 AC01456 AC01501 AC01553 AC01618 AC01762 AC01414 AC01457 AC01502 AC01554 AC01620 AC01763 AC01415 AC01458 AC01503 AC01556 AC01622 AC01766 AC01416 AC01459 AC01504 AC01557 AC01623 AC01767 AC01417 AC01460 AC01505 AC01558 AC01644 AC01770 AC01418 AC01461 AC01506 AC01559 AC01648 AC01779 AC01419 AC01462 AC01507 Ac01560 AC01649 AC01780 AC01420 AC01463 AC01508 AC01561 AC01650 AC01790 AC01421 AC01464 AC01509 AC01562 AC01651 AC01791 AC01422 AC01465 AC01510 AC01563 AC01653 AC01799 AC01423 AC01466 AC01511 AC01564 AC01654 AC01001 AC01028 AC01311 AC01545 AC01610 AC01652 AC01679 AC01797 AC01002 AC01029 AC01312 AC01548 AC01619 AC01664 AC01680 AC01798 AC01003 AC01030 AC01313 AC01549 AC01621 AC01667 AC01681 AC01802 AC01004 AC01043 AC01317 AC01551 AC01624 AC01668 AC01682 AC01803 AC01005 AC01044 AC01331 AC01552 AC01625 AC01669 AC01683 AC01804 AC01006 AC01050 AC01356 AC01555 AC01626 AC01642 AC01684 AC01805 AC01007 AC01051 AC01357 AC01566 AC01627 AC01643 AC01686 AC01806 AC01008 AC01054 AC01358 AC01573 AC01628 AC01645 AC01687 AC01807 AC01009 AC01059 AC01371 AC01581 AC01629 AC01646 AC01703 AC01809 AC01010 AC01078 AC01380 AC01582 AC01630 AC01647 AC01704 AC01810 AC01011 AC01081 AC01387 AC01586 AC01632 AC01652 AC01714 AC01811 AC01012 AC01082 AC01400 AC01587 AC01633 AC01664 AC01739 AC01812 AC01013 AC01083 AC01424 AC01588 AC01636 AC01667 AC01740 AC01813 AC01014 AC01084 AC01431 AC01589 AC01637 AC01668 AC01741 AC01814 AC01015 AC01104 AC01432 AC01590 AC01638 AC01669 AC01742 AC01816 AC01017 AC01105 AC01486 AC01591 AC01639 AC01671 AC01753 AC01817 AC01020 AC01114 AC01494 AC01592 AC01640 AC01672 AC01754 AC01820 AC01021 AC01115 AC01495 AC01595 AC01641 AC01673 AC01758 AC01821 AC01022 AC01116 AC01520 AC01599 AC01642 AC01674 AC01759 AC01823 AC01023 AC01178 AC01525 AC01602 AC01643 AC01675 AC01760 AC01824 AC01024 AC01228 AC01526 AC01603 AC01645 AC01676 AC01761 AC01025 AC01235 AC01530 AC01604 AC01646 AC01677 AC01764 AC01027 AC01310 AC01535 AC01609 AC01647 AC01678 AC01796
• Recalling Firm/ Manufacturer: Abbott Gmbh & Co. KG; Max-Planck-Ring 2; 65205; Wiesbaden Germany
• For Additional Information Contact: Albert Chianello; 877-422-2688
• Manufacturer Reason for Recall: 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 Determined Cause: Under Investigation by firm
• Action: On February 26, 2019, Abbott sent a correction notice to there customers stating to please continue to follow the instructions provided in the Alinity ci series Operations Manual when replacing the bulk solutions. Use caution when accessing bulk solution bottle holders or replacing bulk solution bottles as you may be exposed to a sharp hazard. The Alinity ciseries Operations Manual will be updated in the future to add the appropriate hazard information to the procedure. If the safety interlock or bottle release does not function correctly, please contact your area customer support for assistance. Your Abbott representative will contact you to schedule the placement of hazard labeling in the bulk solution area to increase awareness of this hazard. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
• Quantity in Commerce: 559
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.