ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.

Devices were delivered without the required dry ice.

On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.