BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and lab
FDA device recall Z-0430-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQX
- Quantity affected
- 145 kits
- Distribution
- Product was sold to direct accounts nationwide and international affiliated distributors in Japan, Belize, Taiwan, Canada, Korea, Australia, and the Philippines.
- Date initiated
- 2005-12-01
- Date posted
- 2006-01-24
- Date terminated
- 2006-04-06
- Location
- Sparks, MD
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