Recall Z-1423-2022— Randox Laboratories Ltd.

Name: FDA recall Z-1423-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-09

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2022-06-09, terminated 2024-02-08. It names one FDA 510(k) clearance: K002585. Product: Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD. 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 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..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Terminated
Initiated: 2022-06-09
Terminated: 2024-02-08
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K002585 — RANDOX TRANSFERRINRandox Laboratories, Ltd.·cleared 2001-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.