Product Safety Recalls

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Randox Laboratories Ltd. Recall 90471

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

Randox Laboratories Ltd. Recall 90471 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1423-2022
Event ID90471
Event DescriptionSoluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Product TypeDevices
DistributionUS Nationwide distribution in the state of IL.
Quantity12 kits (US)
Recall ReasonA 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.
Device Classification20220727
Device Code InfoUDI-DI (GTIN): 05055273215557 All lots within expiry
Center Classification Date20220720
Recall Initiation Date20220609
Recalling FirmRandox Laboratories Ltd.
Initial Notification Letter
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