CLASS III Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Soluble Transferrin Receptors (STFR) recalled by Randox Laboratories
Randox Laboratories is recalling Soluble Transferrin Receptors (STFR), distributed nationwide in the US. The recall was initiated on 9 Jun 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1422-2022
- FDA event ID
- 90471
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Jun 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Jun 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +41 days |
| 27 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Where it was distributed
US Nationwide distribution in the state of IL.
Questions about this recall
Is Soluble Transferrin Receptors (STFR) recalled?
Yes. Randox Laboratories recalled Soluble Transferrin Receptors (STFR) on 9 Jun 2022. The recall is Class III and its status is Terminated. Recall number Z-1422-2022.
Why was it recalled?
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.
Which lots are affected?
UDI-DI (GTIN): 05055273215564 All lots within expiry
Where was it sold?
US Nationwide distribution in the state of IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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