Z-2005-2009

Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for...

Name: Z-2005-2009 Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for...
Creator: Roche Diagnostics Corp.
Published: 2009-06-10
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-06-10 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh... on 2009-06-10. The reason FDA records is "There may be a significant negative bias when testing neonate samples". 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-2005-2009
Status: Terminated
Initiated: 2009-06-10
Posted: 2009-09-16
Terminated: 2010-10-29
Recalling firm: Roche Diagnostics GmbH
Product: Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: There may be a significant negative bias when testing neonate samples.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative.
Quantity in commerce: 1,518 of total products
Distribution: International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.
Product codes and lots: All Lots with REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001.

Product code NBW

K070585Class IIAccu-Chek Performa SystemRoche Diagnostics Corp. / cleared 2007-05-25

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)