Date Initiated by Firm | April 14, 2016 |
Create Date | December 08, 2016 |
Recall Status1 |
Terminated 3 on September 19, 2017 |
Recall Number | Z-0725-2017 |
Recall Event ID |
75263 |
510(K)Number | K052914 |
Product Classification |
Photometric method, magnesium - Product Code JGJ
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Product | Magnesium on RX Imola analyser
IVD |
Code Information |
reagent: MG3880 analyser: RX4900 |
Recalling Firm/ Manufacturer |
Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom
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Manufacturer Reason for Recall | According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction. |
FDA Determined Cause 2 | Device Design |
Action | Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com. |
Quantity in Commerce | 15 |
Distribution | Nationwide Distribution The product was only distributed to US Consignees. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JGJ
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