Z-1423-2022Class III

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

Name: Z-1423-2022 Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Creator: Randox Laboratories Ltd.
Published: 2022-06-09
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2022-06-09 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD on 2022-06-09. FDA classified it as Class III and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1423-2022
Classification: Class III
Status: Terminated
Initiated: 2022-06-09
Posted: 2022-07-20
Terminated: 2024-02-08
Recalling firm: Randox Laboratories, Limited
Product: Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Product code: DDG Transferrin, Antigen, Antiserum, Control
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 1.25.3 is installed. Customers were instructed to review results generated with the affected batches in line with the clinical profile of the patient.
Quantity in commerce: 12 kits (US)
Distribution: US Nationwide distribution in the state of IL.
Product codes and lots: UDI-DI (GTIN): 05055273215557 All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1423-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1422-2022	Class III	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1423-2022	Class III	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code DDG

K002585Class IIRandox TransferrinRandox Laboratories, Ltd. / cleared 2001-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)