Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD Recall
Issued July 27, 2022 · Randox Laboratories Ltd.
In July 2022, Randox Laboratories Ltd. recalled the Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Randox Laboratories Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Randox Laboratories Ltd.
- Category
- Health
- Recall date
- July 27, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of IL.
- Recall number
- FDA-Z-1422-2022
- Made in
- Ireland
- Issuing agency
- FDA
In context
- Randox Laboratories Ltd. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.