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U.S. Department of Health and Human Services

Class 2 Device Recall RX Imola

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  Class 2 Device Recall RX Imola see related information
Date Initiated by Firm May 04, 2018
Create Date June 04, 2018
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-2059-2018
Recall Event ID 79968
510(K)Number K052914  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product RX Imola (RX4900)

For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Code Information GTIN 05055273206104. All serial numbers.
Recalling Firm/
Manufacturer		 Randox Laboratories
515 Industrial Blvd
Kearneysville WV 25430-2778
Manufacturer Reason
for Recall		 Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
FDA Determined
Cause 2		 Under Investigation by firm
Action All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.
Quantity in Commerce 41 analyzers
Distribution US Distribution including Puerto Rico and the state of : West Virginia.
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 = JJE and Original Applicant = RANDOX LABORATORIES, LTD.
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