Z-0669-2007

BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in...

Name: Z-0669-2007 BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in...
Creator: Becton Dickinson & Co.
Published: 2007-02-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-02-19 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle... on 2007-02-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0669-2007
Status: Terminated
Initiated: 2007-02-19
Posted: 2007-03-29
Terminated: 2007-07-09
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***
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 528/10 packs
Distribution: Worldwide, including USA, Australia, Canada, Hong Kong, Philippines, Belgium, Japan, Mexico, Singapore, Chile, India, and Venezuela.
Product codes and lots: Lot 6167435, exp 6/30/08

Product code JTN

K822832Class IITicarcillin 75Mcg. Sensi-DiscBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1982-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)