Use caution Medical device recall · FDA · Published July 28, 2021

Accu-Chek Performa Recall: Inaccurate Glucose Results Risk

Roche recalls Accu-Chek Performa test strips because vials may open during shipping, risking humidity damage and inaccurate blood glucose readings.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2352-2021Medical device Accu-Chek ›

Use caution until it’s fixed

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Take action

Contact the company

Recalling firmRoche Diabetes Care, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025

✎ GovInfoNow plain-language explainer

Roche Diabetes Care, Inc. is recalling the Accu-Chek Performa Test Strip and Blood Glucose Monitoring System (Model number 07299702001) due to a labeling correction. The issue involves test strip vials potentially opening inside sealed cartons during shipment. This exposure to humidity can damage the strips, leading to inaccurate results that may cause inappropriate therapy decisions. Read more at govinfonow.com/recall/62130-roche-accu-chek-performa-test-strips-humidity-risk-in-shipment.

Source Summary by GovInfoNow · govinfonow.com/recall/62130-roche-accu-chek-performa-test-strips-humidity-risk-in-shipment · Updated October 13, 2026 · FDA enforcement record: FDA #Z-2352-2021

Cite this page

“Accu-Chek Performa Recall: Inaccurate Glucose Results Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/62130-roche-accu-chek-performa-test-strips-humidity-risk-in-shipment. Based on FDA recall #Z-2352-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2352-2021%22&limit=1).

The FDA announced on July 28, 2021, that Roche Diabetes Care, Inc. is recalling Accu-Chek Performa Test Strips and Blood Glucose Monitoring Systems due to potential humidity damage causing inaccurate results. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Accu-Chek
Product: Performa Test Strip and Blood Glucose Monitoring System
Model number: 07299702001

The hazard

Test strip vials may open while inside sealed cartons during shipment, exposing strips to humidity that could damage them and result in inaccurate readings. These inaccuracies might lead to inappropriate therapy decisions and adverse health consequences.

Context

GovInfoNow's records show Roche Diabetes Care, Inc. has had 9 other recalls 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.

How to tell if you have this one

Look for the Accu-Chek Performa Test Strip and Blood Glucose Monitoring System with Model number 07299702001. This recall applies to all non-expired lots of this product, as it is a labeling correction not specific to any single lot.

Brand
Accu-Chek
Category
Medical device

FDA recall event · 4 products

All 4 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
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2351-2021	Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001; Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.	10,546,420 (US), 19,120,668 (OUS)
Z-2352-2021	Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001; Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.	146,854 (US); 59,815,555 (OUS)
Z-2353-2021	Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001; Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.	1,150,755 (US)
Z-2354-2021	Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001; Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.	9,555,555 (US); 5,128,758 (OUS)

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution.” 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 published this recall 35 days after the firm started it.

Jul 28, 2021Firm started the recall
Aug 26, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/62130-roche-accu-chek-performa-test-strips-humidity-risk-in-shipment">Accu-Chek Performa Recall: Inaccurate Glucose Results Risk (GovInfoNow)</a>

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-2352-2021 (July 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2352-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.