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.
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Products
Becton Dickinson's ProbeTec (tm) ET Instrument
- Brand
- Becton Dickinson & Co.
- UPC
- Instrument serial numbers 1001-2056
Units Affected
1015 units