Roche Diabetes Care, Inc.: Accu-Chek Guide (SC) Kits Recalled for Incorrect Measurement Units

Agency Publication Date: June 21, 2024

Summary

Roche Diabetes Care, Inc. is recalling 48 Accu-Chek Guide (SC) Kits because the blood glucose meters may display measurement units in mmol/L instead of the standard U.S. unit of mg/dL. This error causes blood sugar readings to appear approximately 18 times lower than they actually are, which can lead patients to take unnecessary sugar or carbohydrates for supposed low blood sugar. This defect was identified after three consumer complaints reported the incorrect unit of measure appearing on their devices.

Risk

The meter may provide a dangerously low reading that leads to inappropriate treatment for hypoglycemia, causing unrecognized high blood sugar (hyperglycemia). Over time, this mismanagement of diabetes can lead to serious health events including heart attack, stroke, or organ damage, and may cause fetal harm in pregnant women.

What You Should Do

Check your Accu-Chek Guide (SC) Kit for Product REF Number 08453071001 and GTIN 00365702729100.
Verify if your device's serial number is among the affected units: 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052, 92340120057, 92339744998 (US) or 93040305146 (Canada).
Immediately stop using the meter if it displays units in 'mmol/L' instead of 'mg/dL' and contact your healthcare provider for guidance on managing your blood glucose monitoring.
Contact Roche Diabetes Care, Inc. at their Indianapolis headquarters or through the contact methods provided in the notification letter you received to arrange for a replacement or further instructions.
Call the FDA recall hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Accu-Chek Guide (SC) Kit

Model / REF:

08453071001

UPC Codes:

00365702729100

Lot Numbers:

US: 92339920445

92340117408

92339920116

92339955415

92340120006

92339094787

92340116052

92340120057

92339744998

Canada: 93040305146

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94655

Status: Active

Manufacturer: Roche Diabetes Care, Inc.

Manufactured In: United States

Units Affected: 48 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

Risk

What You Should Do

Check your Accu-Chek Guide (SC) Kit for Product REF Number 08453071001 and GTIN 00365702729100.

Verify if your device's serial number is among the affected units: 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052, 92340120057, 92339744998 (US) or 93040305146 (Canada).

Immediately stop using the meter if it displays units in 'mmol/L' instead of 'mg/dL' and contact your healthcare provider for guidance on managing your blood glucose monitoring.

Contact Roche Diabetes Care, Inc. at their Indianapolis headquarters or through the contact methods provided in the notification letter you received to arrange for a replacement or further instructions.

Call the FDA recall hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.