Recalls / —
—#43266
Product
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***
- FDA product code
- JQX — Nephelometer, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Lot 5075281 Exp 2/14/06*** Lot 5115146 Exp 2/14/06
Why it was recalled
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 (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Co.
- Address
- 7 Loveton Cir, Sparks, Maryland 21152-9212
Distribution
- Distribution pattern
- Product was sold to direct accounts nationwide and international affiliated distributors in Japan, Belize, Taiwan, Canada, Korea, Australia, and the Philippines.
Timeline
- Recall initiated
- 2005-12-01
- Posted by FDA
- 2006-01-24
- Terminated
- 2006-04-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43266. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.