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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Human Assayed MultiSera

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  Class 2 Device Recall Randox Human Assayed MultiSera see related information
Date Initiated by Firm June 11, 2019
Create Date August 06, 2019
Recall Status1 Terminated 3 on May 15, 2020
Recall Number Z-2150-2019
Recall Event ID 83155
510(K)Number K942458  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Human Assayed Multi-Sera Level 2, Model NO. HN1530

Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Code Information 1306UN, 1308UN, 1309UN
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
Manufacturer Reason
for Recall		 The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following: " Review your reagent inventory of these products. Remove all previous versions of the Value Sheets in use and replace with the revised version. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to t echnical.services@ randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.
Quantity in Commerce 149 (US)
Distribution US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
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 = JJY and Original Applicant = RANDOX LABORATORIES, LTD.
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