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Lower risk Medical device recall · FDA · Published February 11, 2022

Abbott Alinity m IRU Recall: Risk of Reaction Vessels Detaching During Transport

Abbott recalls Alinity m Integrated Reaction Units with potential for Reaction Vessels to detach from caps during pipettor robot transport. Affected units have specific lot numbers. Consumers should contact Abbott for details.

🇺🇸 FDA recall #Z-0710-2022Medical deviceAbbott ›
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Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315
✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling Alinity m Integrated Reaction Units (IRU) because Reaction Vessels (RVs) might detach from their caps while being moved by the pipettor robot. This could lead to the RVs falling or causing damage during normal use. The recall affects specific units with listed lot numbers. Read more at govinfonow.com/recall/61154-abbott-alinity-m-iru-recall-risk-of-reaction-vessels-detaching.

Source Summary by GovInfoNow · govinfonow.com/recall/61154-abbott-alinity-m-iru-recall-risk-of-reaction-vessels-detaching · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0710-2022

Cite this page

“Abbott Alinity m IRU Recall: Risk of Reaction Vessels Detaching During Transport.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61154-abbott-alinity-m-iru-recall-risk-of-reaction-vessels-detaching. Based on FDA recall #Z-0710-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2022%22&limit=1).

Why it’s dangerous

The Reaction Vessels (RVs) could detach from their caps while being handled by the pipettor robot during transport. This detachment might cause the RVs to fall or become dislodged, potentially leading to damage or interference with lab processes.

Who’s affected

Users of Abbott Alinity m Integrated Reaction Units with specific lot numbers are affected. Laboratory technicians and healthcare professionals using these units are most at risk.

How to tell if you have this one

Check the lot numbers listed: 766233, 770433, 771200, 771201, or 773642. These units were sold with specific UDI codes and list numbers.

  • Brand
    Abbott
  • Product
    Alinity m Integrated Reaction Units (IRU)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Abbott

    Reach out to Abbott Molecular, Inc. for specific instructions on how to handle affected units.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 21 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: 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: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Oklahoma, Rhode Island, South Dakota, Texas, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Feb 11, 202212. FDA classified it Class II: Mar 2, 202223. Published in FDA’s Enforcement Report: Mar 9, 202234. FDA terminated the recall: Apr 14, 2023420222023
  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-0710-2022 (February 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0710-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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