Recall Z-0669-2007 ยท JTN Susceptibility Test Discs, Antimicrobial
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***
| Date | Mar 29, 2007 (initiated Feb 19, 2007) |
| Status | Terminated |
| 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 |
| Quantity | 528/10 packs |
| Distribution | Worldwide, including USA, Australia, Canada, Hong Kong, Philippines, Belgium, Japan, Mexico, Singapore, Chile, India, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822832 | TICARCILLIN 75MCG. SENSI-DISC Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 18, 1982 |