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Lower risk Medical device recall · FDA · Published October 23, 2025

BD Kiestra Isolate Suspension Cuvette Array: Barcode Errors Prevent Expiration Date

Becton Dickinson recalls BD Kiestra Isolate Suspension Cuvette Array (Catalog No. 246100) due to 2D barcodes with formatting errors that prevent expiration date reading, causing instrument errors.

🇺🇸 FDA recall #Z-0484-2026Medical deviceBecton Dickinson ›
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Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212
✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling BD Kiestra Isolate Suspension Cuvette Array cuvettes because their 2D barcodes have errors that prevent the instrument from reading expiration dates. This causes the instrument to enter an error state and the cuvettes cannot be used. Affected units have specific catalog numbers and lot numbers. Read more at govinfonow.com/recall/51023-bd-kiestra-isolate-suspension-cuvette-array-barcode-errors-prevent-expiration.

Source Summary by GovInfoNow · govinfonow.com/recall/51023-bd-kiestra-isolate-suspension-cuvette-array-barcode-errors-prevent-expiration · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0484-2026

Cite this page

“BD Kiestra Isolate Suspension Cuvette Array: Barcode Errors Prevent Expiration Date.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51023-bd-kiestra-isolate-suspension-cuvette-array-barcode-errors-prevent-expiration. Based on FDA recall #Z-0484-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0484-2026%22&limit=1).

The FDA announced on Oct. 23, 2025, that Becton Dickinson & Co. is recalling BD Kiestra Isolate Suspension Cuvette Arrays due to barcode formatting errors. The hazard prevents analyzing systems from reading expiration dates, causing instrument error states and rendering the cuvettes unusable.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: BD Kiestra Isolate Suspension Cuvette Array
  • Catalog No.: 246100
  • Lot Numbers: LM245590, LM245592, LM245593, LM245594, LM245666
  • Units affected: 29,760

The hazard

The 2D barcodes on the cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls include a BD GasPak EZ Campy Pouch System recall for low CO2 levels (2026-04-07), a product catalog security issue (2025-09-23), and a BD COR System Software recall for false negative results risk (2025-06-23).

How to tell if you have this one

Check for catalog number 246100 and lot numbers LM245590, LM245592, LM245593, LM245594, or LM245666 on the cuvettes. The product was sold with UDI-DI: 30382902461006.

  • Brand
    Becton Dickinson
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Cuvette Lot Numbers

    Identify the lot numbers on the cuvettes (LM245590, LM245592, LM245593, LM245594, or LM245666) to confirm if they are affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, Connecticut, Kentucky, New Jersey, Tennessee, Texas, Utah.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Oct 23, 202512. FDA classified it Class II: Nov 7, 202523. Published in FDA’s Enforcement Report: Nov 19, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Are there any safety risks from using these cuvettes?

No safety risks are associated with using these cuvettes; the issue is a technical error that prevents proper use, not a physical hazard.

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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-0484-2026 (October 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0484-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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