Recall Z-0443-06 ยท JQX Nephelometer, For Clinical Use
Becton Dickinson & Co.
BD PhoenixSpec Nephelometer, Catalog #440910.
| Date | Jan 25, 2006 (initiated Jan 17, 2006) |
| Status | Terminated |
| Reason | A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples. |
| Root cause | Other |
| Action | The recalling firm notified direct accounts by courier and international distributors by e-mail on 01/17/06. The notification advised that the the troubleshooting section in the firm''s nephelometer user''s guide, vers. 2004/12, is incorrect in describing the 'CAL?' message as indicating a default calibration is in use. The recalling firm provided a cautionary sticker in the bulletin and described recommended placement on the device by pictorial. The sticker instructs users not to use the nephelometer if 'CAL?' message appears on the units'' LCD screen. |
| Quantity | 488 units |
| Distribution | The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.