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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Protein Calibrators

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  Class 2 Device Recall Liquid Protein Calibrators see related information
Date Initiated by Firm November 19, 2018
Create Date December 21, 2018
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-0660-2019
Recall Event ID 81664
510(K)Number K031608  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product SP CAL (LIQ), REF IT2692

This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Code Information 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product. - Return the completed response form via email to technical.services@randox.com. If you have any questions, contact RA Specialist by email at maria.kelly@randox.com.
Quantity in Commerce 250 kits (32 kits US / 218 kits OUS)
Distribution US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
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 = JIX and Original Applicant = RANDOX LABORATORIES, LTD.
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