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Lower risk Medical device recall · FDA · Published June 8, 2023

BD Synapsys Informatics Solution: Risk of Patient Data Misassociation

Becton Dickinson recalls BD Synapsys Informatics Solution (Catalog 444150) due to risk of patient demographic data misassociation when using save actions during high system load.

🇺🇸 FDA recall #Z-2099-2023Medical 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 its BD Synapsys Informatics Solution (Catalog Number 444150) because it can misassociate patient data when users process results quickly while the system is near capacity. This could lead to incorrect patient information being linked to medical records. Read more at govinfonow.com/recall/57875-bd-synapsys-informatics-solution-risk-of-patient-data-misassociation.

Source Summary by GovInfoNow · govinfonow.com/recall/57875-bd-synapsys-informatics-solution-risk-of-patient-data-misassociation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2099-2023

Cite this page

“BD Synapsys Informatics Solution: Risk of Patient Data Misassociation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57875-bd-synapsys-informatics-solution-risk-of-patient-data-misassociation. Based on FDA recall #Z-2099-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2023%22&limit=1).

The FDA announced on June 8, 2023, that Becton Dickinson & Co. is recalling the BD Synapsys Informatics Solution, Catalog Number 444150. The recall addresses a risk of mis-association of patient demographic data when users manually report results while the Service Control Unit operates near capacity.

How to tell if you have it

  • BD Synapsys Informatics Solution
  • Catalog Number 444150
  • UDI-DI: 00382904441500

The hazard

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Recent brand recalls include the BD GasPak EZ Campy Pouch System Recall dated 2026-04-07 and the BD Kiestra Isolate Suspension Cuvette Array recall dated 2025-10-23. Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter System Recalls (2026-07-29) and GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (2026-07-31).

How to tell if you have this one

Check for the BD Synapsys Informatics Solution with Catalog Number 444150. The product is sold by Becton Dickinson & Co. and may be used in healthcare settings for patient data management.

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

What to do — step by step

  1. Check Product Details

    Verify if your BD Synapsys Informatics Solution has Catalog Number 444150.

Where it went and when

Where it was distributed

Distributed in 15 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Illinois, Iowa, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Jun 8, 202312. FDA classified it Class II: Jul 5, 202323. Published in FDA’s Enforcement Report: Jul 12, 202332023
  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.

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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-2099-2023 (June 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2099-2023 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