QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

On 01/20/2022, the firm contact via email its international customers regarding that the QMS Tacrolimus Calibrator was recovering between 82 to 94% of its target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. On 03/10/2022, the firm notified its U.S. customer of the issue. Customers were instructed to: 1)Determine if they are using or have inventory of QMS Tacrolimus Calibrator catalog number 10015573, lot 74175462 or lot 74267412. 2)Discontinue use of affected in-date lots, and transition to new lot(s) where corrections have been made. Lot 74395275 and Lot 74459127 have had the testing correction applied and are currently available in stock to replace any of their remaining inventory of lots 74175462 or 74267412. 3)Dispose of the effected lots in accordance with local, regional, national regulations. 4)Contact your health care professional, as appropriate, for further action. " This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected calibrator lots have been transferred. " Tacrolimus results reported with these affected calibrator lots do not need to be reanalyzed. " Retain a copy of this letter for your laboratory records. " Call Technical Service if assistance is needed for lot replacement (free of charge). " Please complete the Acknowledgment & Receipt Form attached to this Notification within 5 days of the date of this letter to Thermo fisher Scientific Technical Service. For questions, contact: -FAX: 888-527-8001 (USA only) or +1-510-979-5420 (outside USA) -PHONE: (+1)-800-232-3342 then press option 2, then option 2, or contact your local country representative. -E-mail: [email protected]