Date Initiated by Firm |
October 10, 2012 |
Date Posted |
February 11, 2013 |
Recall Status1 |
Terminated 3 on June 04, 2013 |
Recall Number |
Z-0801-2013 |
Recall Event ID |
63584 |
Product Classification |
Supplement, culture media - Product Code JSK
|
Product |
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples. |
Code Information |
Lot 1175209 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact |
Earleen C. Parks 913-888-0939
|
Manufacturer Reason for Recall |
The product may contain low level microbial contamination which could result in incorrect results.
|
FDA Determined Cause 2 |
Material/Component Contamination |
Action |
ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization.
The firm request the information form be faxed back confirming receipt of notice.
For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144. |
Quantity in Commerce |
10 units |
Distribution |
Distribution included the states of IL, IN and MI. |
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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