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Lower risk Medical device recall · FDA · Published May 1, 2019

Abbott ARCHITECT C System Mixer Recall: Mixer Blade May Detach Causing Inadequate Sample

Abbott recalls ARCHITECT C System Mixer models LN 09D59-01, 02, 03 due to risk of mixer blade detaching, which can cause inadequate sample mixing in clinical chemistry tests.

🇺🇸 FDA recall #Z-1671-2020Medical deviceAbbott ›
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Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313
✎ GovInfoNow plain-language explainer

Abbott is recalling ARCHITECT C System Mixer models LN 09D59-01, 02, and 03 because the mixer blade may separate from the mixer due to screw and nut failure. This can lead to inadequate mixing of samples and reagents in clinical chemistry tests. Read more at govinfonow.com/recall/67976-abbott-architect-c-system-mixer-recall-mixer-blade-may-detach.

Source Summary by GovInfoNow · govinfonow.com/recall/67976-abbott-architect-c-system-mixer-recall-mixer-blade-may-detach · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1671-2020

Cite this page

“Abbott ARCHITECT C System Mixer Recall: Mixer Blade May Detach Causing Inadequate Sample.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67976-abbott-architect-c-system-mixer-recall-mixer-blade-may-detach. Based on FDA recall #Z-1671-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2020%22&limit=1).

The FDA announced on 2019-05-01 that Abbott Laboratories, Inc. is recalling ARCHITECT C System Mixers due to a hazard where the mixer blade may separate from the mixer. This failure can result in inadequate mixing of samples and reagents.

How to tell if you have it

  • Brand: Abbott
  • Product: ARCHITECT C System Mixer
  • Lot codes: LN 09D59-01, LN 09D59-02, LN 09D59-03

The hazard

According to the FDA, the mixer blade may separate from the mixer due to screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.

Context

GovInfoNow's records show Abbott Laboratories, Inc. has 11 other recalls on record since 2017-09-29. Other recent recalls include the 2022-02-03 Abbott Alinity s System Software Version 2.8.0 Recall and the 2021-07-12 Abbott Alinity s System Recall. Similar recent recalls of other products include the 2026-03-25 Heraeus PALAMIX uno recall and the 2026-06-29 American Contract Systems Convenience Kit Recalls.

How to tell if you have this one

Check if your ARCHITECT C System Mixer has model numbers LN 09D59-01, LN 09D59-02, or LN 09D59-03. These mixers are used with Abbott's ARCHITECT Clinical Chemistry System for automated chemistry tests.

  • Brand
    Abbott
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Mixer Model

    Identify the model number on your ARCHITECT C System Mixer to see if it is one of the recalled models: LN 09D59-01, LN 09D59-02, or LN 09D59-03.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 43 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution  US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: May 1, 201912. FDA classified it Class II: Apr 6, 202023. Published in FDA’s Enforcement Report: Apr 15, 202034. FDA terminated the recall: Jul 2, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1671-2020 (May 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1671-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA