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Lower risk Medical device recall · FDA · Published March 9, 2022

Roche Diabetes Care Software Version 2.5.2: Patient Data Mismatch Risk

Roche Diabetes Care recalls software version 2.5.2 (material number 08888353001) due to potential patient data mismatch when using browser back button. This web application was manufactured in November 2021.

🇺🇸 FDA recall #Z-1008-2022Medical deviceRoche Diabetes Care ›
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Contact the company

Recalling firmRoche Diabetes Care, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025
✎ GovInfoNow plain-language explainer

Roche Diabetes Care is recalling its diabetes management software version 2.5.2 because using the browser's back button can cause patient data mismatches. This affects users who navigate between patients through web applications. The issue could lead to incorrect health information being displayed. Read more at govinfonow.com/recall/60966-roche-diabetes-care-software-version-2-5-2-patient-data.

Source Summary by GovInfoNow · govinfonow.com/recall/60966-roche-diabetes-care-software-version-2-5-2-patient-data · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1008-2022

Cite this page

“Roche Diabetes Care Software Version 2.5.2: Patient Data Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60966-roche-diabetes-care-software-version-2-5-2-patient-data. Based on FDA recall #Z-1008-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2022%22&limit=1).

The FDA announced on March 9, 2022, that Roche Diabetes Care, Inc. recalled its RocheDiabetes Care Platform Software version 2.5.2 due to a potential for patient data mismatch. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Roche Diabetes Care
  • Product: RocheDiabetes Care Platform Software version 2.5.2
  • Material number: 08888353001
  • Date of manufacture: 2021-11
  • Quantity: 81 registered accounts

The hazard

The software may cause a potential for patient data mismatch when using the browser "back" button to navigate between patients, according to the FDA.

Context

GovInfoNow's records show Roche Diabetes Care, Inc. has had nine other recalls on record since June 8, 2017. Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter Software Issue (July 29, 2026), Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026), and Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026).

How to tell if you have this one

Check if you have Roche Diabetes Care Platform Software version 2.5.2 (material number 08888353001) installed. This software was manufactured in November 2021 and is a web application hosted on a server.

  • Brand
    Roche Diabetes Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Update to the latest version of Roche Diabetes Care Platform Software to fix the data mismatch issue.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 17 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Minnesota, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, South Carolina, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Mar 9, 202212. FDA classified it Class II: Apr 26, 202223. Published in FDA’s Enforcement Report: May 4, 202234. FDA terminated the recall: Jan 22, 2025420222025
  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-1008-2022 (March 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1008-2022 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