Food, drugs, devices › Randox Laboratories Ltd.
Device recall: Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Randox Laboratories Ltd. (Crumlin (North), N/A) initiated this device recall on 9 Jun 2022; FDA lists 2 product records under event 90471, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 8 Feb 2024. Initiation: voluntary: firm initiated. Randox Laboratories Ltd. has 52 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Randox Laboratories Ltd., Crumlin (North), N/A, Ireland.
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…"
Distribution
"US Nationwide distribution in the state of IL."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1422-2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD | 12 kits (US) | Class III | Terminated | 27 Jul 2022 |
| Z-1423-2022 | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD | 12 kits (US) | Class III | Terminated | 27 Jul 2022 |
Context
Other enforcement events for Randox Laboratories Ltd.
All 52 events for Randox Laboratories Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of IL."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.