FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***
- Recall number
- Z-0669-2007
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***
- Status
- Terminated
- Initiated
- 2007-02-19
- Posted
- 2007-03-29
- Terminated
- 2007-07-09
- Reason
- Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. The recalling firm received customer reports of false susceptibility results.
- Root cause
- Other
- Action
- The recalling firm ceased distribution of the product on 01/15/07 and subsequently notified US distributors by faxed letter and international consignees by e-mail on 02/19/07. The notification advised distributors to discontinue and return remaining inventory for replacement. The consignees were instructed to return the accompanying response form indicating inventory counts for credit. The notice also requested distributors to provide within three days the end-user lists of those receiving the product for subsequent direct notification by the recalling firm. The notification to consignees was initiated on 02/22/07 by overnight courier. The consignee notification advised that the product will give false susceptible results when testing with the identified QC organism using the Kirby Bauer method. Consignees were instructed to immediately discontinue use and return prouct identified by lot 6167435, EXP 06/30/08 and reply by returning the enclosed response form. The firm recommended to end users, primarily laboratory and testing facilities, that patient isolates yielding susceptible results with the identified lot of Ticarcillin Sensi-disc which had not been tested with the QC organism, be retested and the physicians notified.
- Quantity
- 528/10 packs
- Distribution
- Worldwide, including USA, Australia, Canada, Hong Kong, Philippines, Belgium, Japan, Mexico, Singapore, Chile, India, and Venezuela.
- Lot, serial or model codes
- Lot 6167435, exp 6/30/08
- 510(k) numbers
- K822832
- PMA numbers
- not on file
- Product code
- JTN
- 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
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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