| Class 2 Device Recall Randox | |
Date Initiated by Firm | July 19, 2023 |
Date Posted | August 23, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2448-2023 |
Recall Event ID |
92781 |
510(K)Number | K061056 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays
Catalogue Number: IT2691 |
Code Information |
GTIN: 05055273204032
Batch/
Lot number Expiry Date
590858 28 08 23;
590859 28 08 23;
627222 28Jul 24;
627224 28Jul24;
634886 28Jul24;
634887 28Jul24
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Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
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Manufacturer Reason for Recall | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
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FDA Determined Cause 2 | Under Investigation by firm |
Action | Randox Labs Ltd (Manufacturer) extended recall to the US distributor via Medical Device Correction Letter dated July 19, 2023. The distributor initial contact with customer and follow up contacts via email and telephone. Letter states reason for recall, health risk and action to take:
" Review results generated with the affected batches in line with the clinical profile of the
patient.
" Discuss the contents of this 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. If you have any questions or concerns please contact Rand ox Technical Services. Any customers using batches 590858 and 590859 for Ferritin, please contact technical.services@randox.com
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Quantity in Commerce | 166 units |
Distribution | CA, FL, IL, ME, MI, NC, OH, PA,NJ, |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JIX
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