—#83054

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.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K070585
Affected lot / code info: 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.

Why it was recalled

There may be a significant negative bias when testing neonate samples.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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.

Timeline

Recall initiated: 2009-06-10
Posted by FDA: 2009-09-16
Terminated: 2010-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83054. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.