Z-2570-2011

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH...

Name: Z-2570-2011 ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH...
Creator: Roche Diagnostics Operations, Inc.
Published: 2011-05-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2011-05-18 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips on 2011-05-18. The reason FDA records is "Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2570-2011
Status: Terminated
Initiated: 2011-05-18
Posted: 2011-06-21
Terminated: 2011-10-25
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.
Root cause tag: design
FDA root cause: Component design/selection
Action: Direct accounts were notified by a Roche Diagnostics press release on 5/18/2011 that included the product's name, lot number, and information to withdraw the remaining inventory of lot 470049 from storage
Quantity in commerce: 27,019 units
Distribution: No US distribution, in France Only.
Product codes and lots: Lot Number 470049, expiration date 12/31/2011.

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)