Roche ACCU-CHEK Performa blood glucose meters/kits, 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.
FDA Recall Z-2006-2009 · Posted 2009-09-16
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNBW
Date Initiated2009-06-10
Date Terminated2010-10-29
Product Quantity1,518 of total products
Reason for Recall
There may be a significant negative bias when testing neonate samples.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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