Z-2186-2018Class II

Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001

Name: Z-2186-2018 Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001
Creator: Roche Diabetes Care, Inc.
Published: 2018-05-07
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2018-05-07 / Terminated / root cause: manufacturing process

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the... on 2018-05-07. FDA classified it as Class II and gives the reason as "The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2186-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Posted: 2018-05-09
Terminated: 2020-01-16
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: "On May 7, 2018, the firm sent Urgent Medical Device Correction letters to affected Retailers, Suppliers, and Patients. Patients were instructed to check their test strip supply lot numbers against the recalled lots. Any test strips from the affected lots must be discarded. To get replacement test strips, patients should use one of the following options: o For fastest replacement of your product, please submit your request at https://notices.accu-chek.com o Email Accu-Chek Customer Care at [email protected] and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o For questions regarding this recall, contact Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. Suppliers were instructed to discontinue distribution and dispose of any remaining stock of the affected lots immediately. Suppliers were also asked to forward recall notifications to their customers, including both supplier- and consumer-level customers. Suppliers were asked to complete a faxback form indicating the total number of vials disposed of by the supplier and supplier customers. If you are a supplier and have questions about the information in this notification, please contact your Roche Account Manager. Retailers were instructed to discontinue sale or distribution and dispose of remaining affected lots in stock. Retailers were also asked to provide recall notification to their consumer customers. Retailers may note the quantity disposed and contact their Suppliers to arrange for credit. For questions please contact your wholesaler or the Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. "
Quantity in commerce: 295,248
Distribution: Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Product codes and lots: Lot 476605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2186-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2185-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2186-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2187-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14

Product code LFR

K131029Class IIAccu-Chek Aviva Plus Test StripRoche Diagnostics Operations, Inc. / cleared 2013-08-09

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)