Randox Laboratories Ltd.: Medical Device Recall in 2022 - (Recall #: Z-1423-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 9, 2022

Date Posted: July 27, 2022

Recall Number: Z-1423-2022

Event ID: 90471

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.

Status: Terminated

Product Quantity: 12 kits (US)

Code Information:

UDI-DI (GTIN): 05055273215557 All lots within expiry

Distribution Pattern:

US Nationwide distribution in the state of IL.

Voluntary or Mandated:

Voluntary: Firm initiated