1,518 units Accu-Chek Performa blood glucose strips/kits: inaccurate neonatal results

[notyard]

FDA class II recall:

PRODUCT
1) Roche ACCU-CHEK Performa blood glucose test strips, 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. REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001. Recall # Z-2005-2009;
2) Roche ACCU-CHEK Performa blood glucose meters/kits. 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. REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023. Recall # Z-2006-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 10, 2009. Firm initiated recall is ongoing.
REASON
There may be a significant negative bias when testing neonate samples.
VOLUME OF PRODUCT IN COMMERCE
1,518 units
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