Recall Z-1094-03 ยท LSL Dna-Reagents, Neisseria
Becton Dickinson & Co.
Becton Dickinson's ProbeTec (tm) ET Instrument
| Date | Aug 20, 2003 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1015 units |
| Distribution | Product was distributed to domestic and military end users nationwide and international distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY Becton Dickinson Microbiology Systems, Nov 4, 1999 |