Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1060-04

ACCU-CHEK Inform meter; catalog No. 3035123

Roche Diagnostics GmbH / initiated 2004-06-30 / Terminated

Roche Diagnostics Corp. began a recall of ACCU-CHEK Inform meter; catalog No. 3035123 on . The reason FDA records is "Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1060-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Roche Diagnostics GmbH
Product
ACCU-CHEK Inform meter; catalog No. 3035123.
Product code
NBW System, Test, Blood Glucose, Over The Counter
Reason for recall
Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
FDA root cause
Other
Action
A 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.
Distribution
Nationwide.
Product codes and lots
All units.