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Lower risk Medical device recall · FDA · Published December 11, 2019

Roche Accu-Chek Aviva Plus Strips Recall: Inability to dose test strips

Roche recalls Accu-Chek Aviva Plus Health Network Strips (Catalog 06908349001) due to potential inability to dose test strips, risking delayed blood glucose treatment.

🇺🇸 FDA recall #Z-0997-2020Medical 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 is recalling Accu-Chek Aviva Plus Health Network Strips because they may not dose properly, which could delay blood glucose treatment. This affects people who rely on these strips for diabetes management. Read more at govinfonow.com/recall/66332-roche-accu-chek-aviva-plus-strips-recall-inability-to-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/66332-roche-accu-chek-aviva-plus-strips-recall-inability-to-dose · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0997-2020

Cite this page

“Roche Accu-Chek Aviva Plus Strips Recall: Inability to dose test strips.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66332-roche-accu-chek-aviva-plus-strips-recall-inability-to-dose. Based on FDA recall #Z-0997-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2020%22&limit=1).

Roche Diabetes Care, Inc. recalled Accu-Chek Aviva Plus Health Network Strips on Dec. 11, 2019, according to the FDA. The strips may fail to dose, potentially delaying treatment decisions for blood glucose monitoring.

How to tell if you have it

  • Accu-Chek Aviva Plus Health Network Strips intended for Blood Glucose Monitoring System
  • Catalog Number: 06908349001
  • Lot Number: 497864
  • NDC: 65702-0438-10
  • UPC: 3-65702-43810-1

The hazard

The hazard is an inability to dose the test strips, which may result in a temporary inability to get a result. This could lead to a delay in treatment and/or therapy decisions.

Context

GovInfoNow's records show Roche Diabetes Care, Inc. has 9 other recalls on record since June 8, 2017. Other recent recalls of similar products include the Roche Accu-Chek Guide (SC) Kit recall on May 13, 2024, and the Roche Diabetes Care Software Version 2.5.2 recall on March 9, 2022. The FDA also announced the Roche Elecsys Anti-TSHR Assay Recall on Nov. 21, 2025.

How to tell if you have this one

Check for Catalog Number 06908349001 on the strip packaging. The lot number 497864 and NDC 65702-0438-10 are also associated with this recall.

  • Brand
    Roche Diabetes Care
  • Product
    Accu-Chek Aviva Plus Health Network Strips
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide: Foreign: Austalia, India
Recall numberProduct, codes & lotsQuantity
Z-0997-2020Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001; Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-182,332 vials
Z-0998-2020Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001; Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-792,836 vials
Z-0999-2020ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020; Lot Number: 49828761,329 units (OUS)
Based on the official FDA remedy

What to do — step by step

  1. Check Strip Packaging

    Look for Catalog Number 06908349001 on the strip packaging to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide: Foreign: Austalia, India” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Dec 11, 201912. FDA classified it Class II: Feb 5, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Jul 8, 2022420192022
  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-0997-2020 (December 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0997-2020 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