Becton Dickinson's ProbeTec (tm) ET Instrument
FDA device recall Z-1094-03 · posted 2003-08-20 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSL
- Quantity affected
- 1015 units
- Distribution
- Product was distributed to domestic and military end users nationwide and international distributors.
- Date initiated
- 2003-07-21
- Date posted
- 2003-08-20
- Date terminated
- 2003-11-19
- Location
- Sparks, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY (K984631) | Becton Dickinson Microbiology Systems | 1999-11-04 |