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Class 2 Device Recall LYFODISK |
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Date Initiated by Firm |
October 06, 2014 |
Create Date |
March 03, 2022 |
Recall Status1 |
Terminated 3 on January 17, 2023 |
Recall Number |
Z-0713-2022 |
Recall Event ID |
89451 |
510(K)Number |
K861022
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Product Classification |
Kit, quality control for culture media - Product Code JTR
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Product |
LYFO-DISK, Quality control kit for culture media, sold as:
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 |
Code Information |
Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-74-5 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-5 (04/22/2015), 959-75-11 (04/22/2015), and 959-77-2 (10/21/2015)
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Recalling Firm/ Manufacturer |
Microbiologics Inc 200 Cooper Ave N Saint Cloud MN 56303-4440
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For Additional Information Contact |
Becky Neu 320-229-7073
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Manufacturer Reason for Recall |
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Microbiologics notified customers on about 10/06/2014 via letter titled "E.faecalis Gentamicin Susceptibility Notification." Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected.
Questions or concerns can be directed to the Technical Support team at 320.229.7064 or techsupport@microbiologics.com. |
Quantity in Commerce |
153 units |
Distribution |
Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam. |
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 = JTR and Original Applicant = MICRO-BIO-LOGICS
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