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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Roche Diabetes Care, Inc.: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Agency Publication Date: February 5, 2020
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Affected Products

Product: 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

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Product: Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7

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Number
Product: ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Lot Number: 498287

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Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84518
Status: Resolved
Manufacturer: Roche Diabetes Care, Inc.
Manufactured In: United States
Units Affected: 3 products (82,332 vials; 92,836 vials; 61,329 units (OUS))

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.