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
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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
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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 |
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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 = CFJ
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