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U.S. Department of Health and Human Services

Class 3 Device Recall STFR

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  Class 3 Device Recall STFR see related information
Date Initiated by Firm June 09, 2022
Create Date July 20, 2022
Recall Status1 Terminated 3 on February 08, 2024
Recall Number Z-1422-2022
Recall Event ID 90471
510(K)Number K002585  
Product Classification Transferrin, antigen, antiserum, control - Product Code DDG
Product Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Code Information UDI-DI (GTIN): 05055273215564 All lots within expiry
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 9, 2022, the firm notified customers of the recall via email. The issue only affects Siemens Atellica CH analyzer users. No action is required if the assay is being run on other platforms. The issue will be resolved in Atellica Solution Software (SW) version 1.25.3. Until all Atellica CH analyzers in the laboratory are updated to SW 1.25.3, the assay can be run by Open Channel. Please contact applications@randox.com for an Atellica CH Open Channel application sheet. If the assay is not run by Open Channel prior to installation of SW version 1.25.3, the assay must be re-calibrated once 1.25.3 is installed. Customers were instructed to review results generated with the affected batches in line with the clinical profile of the patient.
Quantity in Commerce 12 kits (US)
Distribution US Nationwide distribution in the state of IL.
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 = DDG and Original Applicant = RANDOX LABORATORIES, LTD.
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