Recall of Ortho Summit Processor Instrument

DATE RECALL INITIATED:

April 17, 2001

PRODUCT / LOT NUMBER

Ortho Summit Processor Model#: 135028

MANUFACTURER:

Ortho Clinical Diagnostics
Raritan, NJ 08869

REASON:

The recalled processor is used in ELISA screening for infectious diseases in human blood. The instrument fails in processing microwell plates in that it washes other columns more times than required by the package insert and fails to wash row 12. The instrument also fails to display an error message alerting the user of an invalid test.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.