| Class 2 Device Recall SensiDisc |  |
Date Initiated by Firm | February 19, 2007 |
Date Posted | March 29, 2007 |
Recall Status1 |
Terminated 3 on July 09, 2007 |
Recall Number | Z-0669-2007 |
Recall Event ID |
37405 |
510(K)Number | K822832 |
Product Classification |
in vitro diagnostic - Product Code JTN
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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*** |
Code Information |
Lot 6167435, exp 6/30/08 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir Sparks MD 21152-9212
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For Additional Information Contact | Amy Mahns 410-316-4035 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JTN
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