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U.S. Department of Health and Human Services

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

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 Class 3 Device Recall IMMUNOASSAY PREMIUM LEVEL 1 (IA Premium)see related information
Date Initiated by FirmFebruary 07, 2019
Create DateApril 08, 2019
Recall Status1 Terminated 3 on June 08, 2020
Recall NumberZ-1105-2019
Recall Event ID 82184
510(K)NumberK040379 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductImmunoassay Premium Controls, Model Numbers IA2633 and IA2638 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: 440941  1720EC
FEI Number 1000361607
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
ActionUrgent 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 Commerce58
DistributionThe products were distributed to the following US states: WV and Puerto Rico.
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 = JJY
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