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.
|