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U.S. Department of Health and Human Services

Class 2 Device Recall Lactate Dehydrogenase LP and Lactate Dehydrogenase PL

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  Class 2 Device Recall Lactate Dehydrogenase LP and Lactate Dehydrogenase PL see related information
Date Initiated by Firm August 11, 2020
Create Date September 12, 2020
Recall Status1 Terminated 3 on October 15, 2020
Recall Number Z-2962-2020
Recall Event ID 86236
510(K)Number K970684  
Product Classification Nad reduction/nadh oxidation, lactate dehydrogenase - Product Code CFJ
Product Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
Code Information GTIN: 05055273204124;  Lot Numbers: 480483 495947 523902 536342 
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction notification letters dated 8/5/20 were issued to customers. Action to be taken: " Review your instrument testing order in line with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and enable additional pipette washes. " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and ensure all operators are aware of the recommendations. " Discuss the contents of th is notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns, please contact Randox Technical Services.
Quantity in Commerce 21
Distribution US Nationwide distribution including in the states of WV, and Puerto Rico.
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 = CFJ and Original Applicant = RANDOX LABORATORIES, LTD.
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