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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 Imolasee related information
Date Initiated by FirmMay 04, 2018
Create DateJune 04, 2018
Recall Status1 Terminated 3 on June 16, 2020
Recall NumberZ-2059-2018
Recall Event ID 79968
510(K)NumberK052914 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductRX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Code Information GTIN 05055273206104. All serial numbers.
FEI Number 3003059701
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
ActionAll 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 Commerce41 analyzers
DistributionUS Distribution including Puerto Rico and the state of : West Virginia.
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 = JJE
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