Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0735-04

NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument)

bioMerieux, Inc. / initiated 2004-02-26 / Terminated

Biomerieux, Inc. began a recall of NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument) on . The reason FDA records is "Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0735-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
bioMerieux, Inc.
Product
NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall
Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
FDA root cause
Other
Action
This correction is being handled as an instrument repair (rework) by bioMerieux Field Service; therefore no communication has been sent to the customer sites. The repair involves heat sink replacement or use of insulating tape on the rear side of the keypad.
Quantity in commerce
3 units
Distribution
CT, MD, MT
Product codes and lots
Catalog (or Product) number 285204, Serial Number 36061, 36065 and 36068