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U.S. Department of Health and Human Services

Class 3 Device Recall IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1)

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  Class 3 Device Recall IMMUNOASSAY PREMIUM PLUS LEVEL 1 (IA PREMIUM PLUS 1) see related information
Date Initiated by Firm February 07, 2019
Create Date April 08, 2019
Recall Status1 Terminated 3 on June 08, 2020
Recall Number Z-1106-2019
Recall Event ID 82184
510(K)Number K140522  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112

Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Code Information Lot codes: 1714EC  430312  432364
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
FDA Determined
Cause 2		 Employee error
Action Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.
Quantity in Commerce 12
Distribution The products were distributed to the following US states: WV and Puerto Rico.
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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