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Class 2 Device Recall Liquid Protein Calibrators |
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Date Initiated by Firm |
August 09, 2019 |
Create Date |
November 04, 2019 |
Recall Status1 |
Terminated 3 on January 08, 2021 |
Recall Number |
Z-0283-2020 |
Recall Event ID |
83791 |
510(K)Number |
K061056
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Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product |
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems |
Code Information |
Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
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Manufacturer Reason for Recall |
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
1. Review your reagent inventory and replace the value sheet with the new values provided.
2. Review results generated with the affected batches in line with the clinical profile of the patient.
3. Discuss the contents of this notice with your Medical Director.
4. Complete and return the response form 12187-QA to teclhnical.services@randox.com within five working days. |
Quantity in Commerce |
100 kits |
Distribution |
US Nationwide distribution in the states of WV, ME, NJ, CA, 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 = JIX and Original Applicant = RANDOX LABORATORIES, LTD.
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