Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Summary
The FDA issued a Class III for Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only) by Randox Laboratories Ltd.. Reason: A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint.
Details
Source
Device Recall
External ID
Z-1422-2022
Action Date
2022-07-27
Status
Terminated
Category
device
Product Description
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Lot/Code Info: UDI-DI (GTIN): 05055273215564 All lots within expiry
Quantity Affected: 12 kits (US)
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.
Distribution
US Nationwide distribution in the state of IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-09
Company
Crumlin (North), N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories Ltd. have FDA actions?
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1422-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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