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U.S. Department of Health and Human Services

Class 2 Device Recall Remel MH w/oxacillin superpack cs/ 500 seg/flask, ref R01626

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 Class 2 Device Recall Remel MH w/oxacillin superpack cs/ 500 seg/flask, ref R01626see related information
Date Initiated by FirmMay 04, 2018
Create DateJune 08, 2018
Recall Status1 Terminated 3 on December 19, 2018
Recall NumberZ-2137-2018
Recall Event ID 80068
510(K)NumberK850291 
Product Classification Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
Productremel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Code Information Lot: 307200
Recalling Firm/
Manufacturer		 Thermo Fisher
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
Manufacturer Reason
for Recall		Product may fail performance testing for S aureus ATCC 43300.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm initiated the recall by letter on 05/04/2018. The letter stated the following: "Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action." For questions contact Technical Services Department at 800-255-6730 or 913-888-0939.
Quantity in Commerce67 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JTZ
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