Recall Z-0430-06 ยท JQX Nephelometer, For Clinical Use
Becton Dickinson & Co.
BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA***
| Date | Jan 24, 2006 (initiated Dec 1, 2005) |
| Status | Terminated |
| Reason | A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity. |
| Root cause | Other |
| Action | The recalling firm notified consignees by phone, fax and e-mail on 12/01/05. The notification advised that nephelometers displaying 'CAL' error messages on the LED should not be used until calibrated with a different kit lot. Consignees were requested to discard referenced lots for replacement. A response form was included in the notification. |
| Quantity | 145 kits |
| Distribution | Product was sold to direct accounts nationwide and international affiliated distributors in Japan, Belize, Taiwan, Canada, Korea, Australia, and the Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.