Device Recall SensiDisc 의 리콜

Recall

37405

Class 2

Z-0669-2007

2007-02-19

2007-03-29

Terminated

United States

2007-07-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50497

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.

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.