Date Initiated by Firm |
October 17, 2014 |
Date Posted |
November 10, 2014 |
Recall Status1 |
Terminated 3 on February 13, 2017 |
Recall Number |
Z-0200-2015 |
Recall Event ID |
69521 |
510(K)Number |
K831469
|
Product Classification |
Supplement, culture media - Product Code JSK
|
Product |
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg.
A growth supplement for the isolation of Legionella. |
Code Information |
Lot Number: 1451506 Expiration: 26Feb2016 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact |
Scott A. Kendall 770-409-0713
|
Manufacturer Reason for Recall |
Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers. |
Quantity in Commerce |
16/10/100 ml, vial, pkgs |
Distribution |
Distributed in the states of ND, VT and TX. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = JSK and Original Applicant = OXOID U.S.A., INC.
|