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U.S. Department of Health and Human Services

Class 2 Device Recall remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K10ML

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  Class 2 Device Recall remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K10ML see related information
Date Initiated by Firm August 13, 2018
Create Date September 07, 2018
Recall Status1 Terminated 3 on June 18, 2019
Recall Number Z-3019-2018
Recall Event ID 80813
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product remel THIOGLYCOLLATE MEDIUM, REF 05152
Code Information Lot number: 258192
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact
913-895-4077
Manufacturer Reason
for Recall		 Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce 48 units
Distribution US, Canada, Singapore
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.
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