Recalls / —
—#28655
Product
Becton Dickinson's ProbeTec (tm) ET Instrument
- FDA product code
- LSL — Dna-Reagents, Neisseria
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K984631
- Affected lot / code info
- Instrument serial numbers 1001-2056
Why it was recalled
Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Co.
- Address
- 7 Loveton Circle, Sparks, Maryland 21152
Distribution
- Distribution pattern
- Product was distributed to domestic and military end users nationwide and international distributors.
Timeline
- Recall initiated
- 2003-07-21
- Posted by FDA
- 2003-08-20
- Terminated
- 2003-11-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #28655. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.