ClearanceBrief
Recall Z-1061-04 ยท NBW System, Test, Blood Glucose, Over The Counter

Roche Diagnostics Corp.

ACCU-CHEK Inform base unit; catalog no. 3035131.

DateJul 20, 2004 (initiated Jun 30, 2004)
StatusTerminated
ReasonExposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
Root causeOther
ActionA recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K003846ACCU-CHEK INFORM METER
Roche Diagnostics Corp., Mar 19, 2001
K012210MODIFICATION TO ACCU-CHEK INFORM METER
Roche Diagnostics Corp., Aug 9, 2001