FDA Medical Device Recalls (openFDA)
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***
- Recall number
- Z-0430-06
- Recalling firm
- Becton Dickinson & Co.
- 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***
- Status
- Terminated
- Initiated
- 2005-12-01
- Posted
- 2006-01-24
- Terminated
- 2006-04-06
- 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.
- Lot, serial or model codes
- Lot 5075281 Exp 2/14/06*** Lot 5115146 Exp 2/14/06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQX
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28