FDA Device

ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no. 03537536001 with meter model no. 2138930; Ref. no. 03537536001 with meter model no. 3288650.

Hazard

The meter gives a strip error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error and the manual only instructs the user to retest with a new strip using a larger drop of blood.

What You Should Do

Remedy

A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

Products

ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no.
Brand
Roche Diagnostics Corp.
UPC
All units.

Units Affected

55,189 meters (for all Recalls Z-1354-1371-06)