Recall Z-1422-2022 ยท DDG Transferrin, Antigen, Antiserum, Control
Randox Laboratories Ltd.
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
| Date | Jun 9, 2022 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 12 kits (US) |
| Distribution | US Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002585 | RANDOX TRANSFERRIN Randox Laboratories, Ltd., Feb 5, 2001 |