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U.S. Department of Health and Human Services

Class 3 Device Recall Diamedix IsMumps IgG Enzyme Immunoassay Test Kit

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 Class 3 Device Recall Diamedix IsMumps IgG Enzyme Immunoassay Test Kitsee related information
Date Initiated by FirmJanuary 05, 2018
Create DateJuly 28, 2018
Recall Status1 Terminated 3 on November 05, 2019
Recall NumberZ-2573-2018
Recall Event ID 80441
510(K)NumberK991274 
Product Classification Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
ProductDiamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Code Information Lot S0406 Exp. 05/31/2018
Recalling Firm/
Manufacturer		 Diamedix Corporation
14100 Nw 57th Ct
Miami Lakes FL 33014-3107
For Additional Information ContactTechnical Service Department
305-324-2307
Manufacturer Reason
for Recall		Contains a gel-like contaminant that may affect product performance.
FDA Determined
Cause 2		Under Investigation by firm
ActionDiamedix sent a letter dated January 5th, 2018 was sent to all their customer with the following: Products contains a gel-like contaminant that may affect product performance.An inspection of the product in the Diamedix inventory confirmed this observation. Although, no failed runs have been directly attributed this issue, we feel that the best course of action is to replace the affected diluent. If you are using the reagent lot specified above, please discontinue use immediately. In order to process your replacement, please complete the attached Certificate of Destruction and return this document to Diamedix Customer Service via email: CustomerService@erbadiagnostics.com or fax to (305) 418- 2321. If you have further questions or concerns you may contact our Technical Service Department at (305) 324-2307 or (800) 433-0945. Please be assured that Diamedix Corporation is working diligently to resolve the issues with this product. We apologize for any inconvenience that this may have caused and we thank you for your continued patience and support. Sincerely, Tracy Chadwrick Director, QA/QC
Quantity in Commerce505
DistributionAZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
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 = LJY
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