Class II U.S. Food and Drug Administration

Abbott Laboratories Alinity ci-series System Control Module , REF: 03R70-01, 03R70-20 recall: Abbott Laboratories is recalling their Alinity ci-series System Control

Recall published 10 months ago

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0961-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott Laboratories
Product type
Medical devices
Units affected
11653
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00380740137410. GTIN: 06952999490048. Software versions 3.6.1 and lower. Serial Numbers: SCM01010 SCM01012 SCM01016 SCM01035 SCM01043 SCM01051 SCM01063 SCM01069 SCM01075 SCM01076 SCM01078 SCM01082 SCM01085 SCM01086 SCM01087 SCM01088 SCM01092 SCM01093 SCM01094 SCM01095 SCM01098 SCM01099 SCM01101 SCM01102 SCM01106 SCM01107 SCM01110 SCM01115 SCM01116 SCM01120 SCM01121 SCM01122 SCM01123 SCM01124 SCM01126 SCM01127 SCM01128 SCM01129 SCM01132 SCM01134 SCM01135 SCM01136 SCM01137 SCM01138 SCM01142 SCM01143 SCM01149 SCM01150 SCM01151 SCM01154 SCM01163 SCM01166 SCM01170 SCM01171 SCM01172 SCM01174 SCM01175 SCM01176 SCM01179 SCM01180 SCM01181 SCM01184 SCM01192 SCM01193 SCM01194 SCM01196 SCM01197 SCM01198 SCM01199 SCM01200 SCM01201 SCM01203 SCM01204 SCM01205 SCM01207 SCM01211 SCM01213 SCM01216 SCM01217 SCM01219 SCM01220 SCM01221 SCM01222 SCM01223 SCM01224 SCM01225 SCM01226 SCM01229 SCM01230 SCM01232 SCM01236 SCM01237 SCM01238 SCM01239 SCM01240 SCM01244 SCM01247 SCM01249 SCM01251 SCM01252 SCM01253 SCM01254 SCM01255 SCM01256 SCM01257 SCM01258 SCM01267 SCM01268 SCM01269 SCM01270 SCM01271 SCM01273 SCM01274 SCM01277 SCM01279 SCM01281 SCM01282 SCM01283 SCM01284 SCM01286 SCM01289 SCM01290 SCM01291 SCM01293 SCM01294 SCM01297 SCM01298 SCM01300 SCM01301 SCM01302 SCM01305 SCM01306 SCM01307 SCM01308 SCM01310 SCM01312 SCM01313 SCM01314 SCM01315 SCM01316 SCM01317 SCM01320 SCM01321 SCM01323 SCM01326 SCM01328 SCM01333 SCM01334 SCM01335 SCM01336 SCM01337 SCM01338 SCM01339 SCM01340 SCM01341 SCM01342 SCM01343 SCM01344 SCM01345 SCM01346 SCM01348 SCM01349 SCM01350 SCM01354 SCM01355 SCM01356 SCM01357 SCM01361 SCM01362 SCM01365 SCM01368 SCM01370 SCM01371 SCM01372 SCM01373 SCM01374 SCM01375 SCM01376 SCM01377 SCM01378 SCM01379 SCM01380 SCM01381 SCM01382 SCM01383 SCM01385 SCM01386 SCM01387 SCM01388 SCM01389 SCM01393 SCM01394 SCM01395 SCM01396 SCM01397 SCM01399 SCM01401 SCM01402 SCM01403 SCM01404 SCM01405 SCM01406 SCM01407 SCM01408 SCM01409 SCM01411 SCM01412 SCM01414 SCM01415 SCM01416 SCM01417 SCM01418 SCM01421 SCM01422 SCM01423 SCM01424 SCM01425 SCM01429 SCM01430 SCM01431 SCM01432 SCM01433 SCM01434 SCM01437 SCM01438 SCM01439 SCM01440 SCM01442 SCM01443 SCM01444 SCM01445 SCM01446 SCM01447 SCM01448 SCM01449 SCM01450 SCM01451 SCM01452 SCM01453 SCM01454 SCM01455 SCM01456 SCM01457 SCM01458 SCM01460 SCM01461 SCM01462 SCM01465 SCM01466 SCM01467 SCM01468 SCM01469 SCM01470 SCM01471 SCM01473 SCM01474 SCM01475 SCM01476 SCM01478 SCM01479 SCM01480 SCM01481 SCM01483 SCM01485 SCM01486 SCM01487 SCM01489 SCM01491 SCM01492 SCM01493 SCM01494 SCM01495 SCM01496 SCM01497 SCM01499 SCM01501 SCM01503 SCM01504 SCM01505 SCM01506 SCM01508 SCM01511 SCM01512 SCM01513 SCM01515 SCM01517 SCM01518 SCM01519 SCM01524 SCM01525 SCM01526 SCM01527 SCM01528 SCM01529 SCM01530 SCM01531 SCM01532 SCM01534 SCM01535 SCM01536 SCM01539 SCM01540 SCM01542 SCM01544 SCM01545 SCM01547 SCM01548 SCM01553 SCM01556 SCM01557 SCM01558 SCM01560 SCM01561 SCM01562 SCM01563 SCM01564 SCM01566 SCM01567 SCM01568 SCM01569 SCM01570 SCM01571 SCM01572 SCM01575 SCM01576 SCM01577 SCM01579 SCM01580 SCM01581 SCM01582 SCM01584 SCM01586 SCM01587 SCM01588 SCM01589 SCM01593 SCM01594 SCM01595 SCM01597 SCM01598 SCM01599 SCM01600 SCM01601 SCM01602 SCM01603 SCM01604 SCM01605 SCM01607 SCM01608 SCM01609 SCM01610 SCM01611 SCM01613 SCM01615 SCM01616 SCM01617 SCM01618 SCM01619 SCM01620 SCM01622 SCM01623 SCM01624 SCM01625 SCM01627 SCM01630 SCM01631 SCM01632 SCM01633 SCM01634 SCM01635 SCM01636 SCM01638 SCM01641 SCM01642 SCM01645 SCM01647 SCM01648 SCM01649 SCM01650 SCM01651 SCM01652 SCM01654 SCM01655 SCM01657 SCM01659 SCM01660 SCM01661 SCM01662 SCM01665 SCM01666 SCM01668 SCM01669 SCM01670 SCM01678 SCM01680 SCM01681 SCM01682 SCM01683 SCM01684 SCM01686 SCM01687 SCM01688 SCM01689 SCM01690 SCM01693 SCM01697 SCM01698 SCM01699 SCM01700 SCM01701 SCM01704 SCM01705 SCM01707 SCM01708 SCM01709 SCM01711 SCM01712 SCM01714 SCM01715 SCM01716 SCM01717 SCM01718 SCM01719 SCM01720 SCM01721 SCM01722 SCM01725 SCM01728 SCM01729 SCM01730 SCM01731 SCM01732 SCM01733 SCM01…
UPC codes
06952999490048

Products covered by this recall

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 06952999490048

Model or item number

On the rating label, the box or the instruction sheet.

  • 03R70-01
  • 03R70-20 — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Abbott Laboratories — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Abbott Laboratories — 1915 Hurd Dr, Irving, TX, 75038-4313

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott Laboratories medical devices recalled?

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 06952999490048; model number 03R70-01, 03R70-20 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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