Z-2352-2021Class II

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Name: Z-2352-2021 Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Creator: Roche Diabetes Care, Inc.
Published: 2021-07-28
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2021-07-28 / Open, Classified / root cause: packaging

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 on 2021-07-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2352-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-28
Posted: 2021-08-26
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences. ACTIONS REQUIRED BY USERS: 1. Check vials of affected test strips before use. DO NOT use test strips if: - The vial is open or damaged before using the test strips for the first time - The cap is not fully closed - You see any damage to the cap or vial, or - Anything prevents the cap from closing properly 2. DO NOT perform control testing if you open a sealed carton and ay of the vials inside meet the criteria listed above. 3. Contact Accu-Chek Customer Care for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat. Please have the affected products available. 4. Complete and return the business reply letter to the recalling firm. 5. Dispose of the affected test strips and vial according to your local guidelines. Contact Accu-Chek Customer Care if you have questions regarding the information in this Urgent Medical Device Correction(UMDC) by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat.
Quantity in commerce: 146,854 (US); 59,815,555 (OUS)
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2352-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2351-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-26
Z-2352-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-26
Z-2353-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-26
Z-2354-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-26

Product code LFR

K133741Class IIACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics / cleared 2014-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)