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U.S. Department of Health and Human Services

Class 3 Device Recall Immunoassay Premium Plus Controls

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  Class 3 Device Recall Immunoassay Premium Plus Controls see related information
Date Initiated by Firm August 11, 2017
Create Date March 12, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0970-2018
Recall Event ID 79076
510(K)Number K140522  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Code Information Catalog numbers:  IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)
Recalling Firm/
Manufacturer		 Randox Laboratories
515 Industrial Blvd
Kearneysville WV 25430-2778
Manufacturer Reason
for Recall		 The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
FDA Determined
Cause 2		 Device Design
Action On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com
Quantity in Commerce 199 Kits
Distribution Distribution US nationwide.
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 LIMITED
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