Recall Z-1284-2022 ยท MLM Enzyme Immunoassay, Tracrolimus
Microgenics Corporation
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
| Date | Jan 20, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 correcti |
| Quantity | 615 kits |
| Distribution | U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS Microgenics Corp., Jul 11, 2013 |