FDA Device

Becton Dickinson's ProbeTec (tm) ET Instrument

Hazard

Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

What You Should Do

Remedy

The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.

Products

Becton Dickinson's ProbeTec (tm) ET Instrument
Brand
Becton Dickinson & Co.
UPC
Instrument serial numbers 1001-2056

Units Affected

1015 units