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U.S. Department of Health and Human Services

Class 3 Device Recall LYSO Disk

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  Class 3 Device Recall LYSO Disk see related information
Date Initiated by Firm March 02, 2017
Create Date February 10, 2022
Recall Status1 Terminated 3 on April 22, 2022
Recall Number Z-0637-2022
Recall Event ID 89412
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product LYSO Disk(TM) labeled as containing Actinomyces odontolyticus.

Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Code Information Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Tina Sobania
320-310-9217
Manufacturer Reason
for Recall		 Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Microbiologics notified customers on about 03/02/2017, via letter titled "Medical Device Recall." Customers were instructed to: 1. DO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory. 2. QUARANTINE or DISCARD the product to prevent further use. 3. RETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box Attention: Technical Manager. 4. Acknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to tsobania@microbiolgics.com or by faxing to 320.253.6250.
Quantity in Commerce 1 unit
Distribution International distribution in the countries of Canada and Germany.
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 = JTR and Original Applicant = MICRO-BIO-LOGICS
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